Smiths Medical Asd medical device reports that give this manufacturer

Name type: Device manufacturer, as written on reports

What a report is

A report is not proof that the device was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Device Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Sep 2026.

FDA also says:

Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use.
Source: openFDA, Device Adverse Event Overview. The site read the page on 2 Oct 2026.

MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From November 2003 to May 2026, FDA received 59,484 medical device reports that give Smiths Medical Asd as the manufacturer. A manufacturer name is as written on the report, so a subsidiary or a different spelling can be a separate name.

FDA received 90 reports in the 12 months to September 2026 and 10,118 in the 12 months before. FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.

Of the 3,444,740 device reports that FDA received in the 12 months to September 2026, 90 (under 0.1%) give Smiths Medical Asd as the manufacturer. Voluntary reports were 5.8% of the reports that name this manufacturer and 0.9% of all device reports.

The number of people who use the product is not in the data. A count is not a rate.

Why manufacturers report

FDA says:

Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices.
Source: FDA Center for Devices and Radiological Health, Medical Device Reporting (MDR): How to Report Medical Device Problems. Content current as of 27 Mar 2025. The site read the page on 2 Oct 2026.

Data version

openFDA MAUDE release of 23 Oct 2026. Reports received through 30 Sep 2026.

Brand names

The table has the 79 brand pages with 5 or more reports that give this manufacturer. 80 brand pages have a report in all. The rows are in order of name. A brand page with fewer reports is not in the table.

FDA says:

MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on 2 Oct 2026.

Brand names in the reports that give Smiths Medical Asd as the manufacturer, in order of name
Brand name	Product code	Reports	Reports, 12 months to September 2026
Bivona	Tube tracheostomy and tube cuff	592	11
Bivona Customized Tracheostomy Tubes	Tube tracheostomy and tube cuff	126	22
Bivona Flextend Pediatric and Neonatal Trach Tube	Tube tracheostomy and tube cuff	65	42
Bivona Tracheostomy Tube Neonatal/Pediatric	Tube tracheostomy and tube cuff	179	6
Cadd	Pump, infusion	2,745	8
CADD Administration Set	Set, administration, intravascular	654	235
Cadd Administration Sets	Set, administration, intravascular	252	1
Cadd Administration Sets - Flow Stop	Set, administration, intravascular	96	20
Cadd Cadd-Legacy 1 Pump	Pump, infusion	449	0
Cadd Cadd-Prizm Vip Ambulatory Infusion Pump	Pump, infusion	154	0
Cadd Cadd-Solis Vip Ambulatory Infusion Pump	Pump, infusion	163	0
Cadd Cassette 100ml W/Flowstop	Set, i.v. fluid transfer	367	0
Cadd Cassette Reservoir	Set, administration, intravascular	115	3
Cadd Cassette Reservoirs	Set, administration, intravascular	322	7
Cadd Cassette Reservoirs - Flow Stop	Set, administration, intravascular	67	0
CADD Cleo Infusion Set	Set, administration, intravascular	271	2,122
Cadd Cleo Infusion Sets	Set, administration, intravascular	161	0
CADD Extension Set	Set, administration, intravascular	311	178
Cadd Extension Sets	Set, administration, intravascular	211	1
Cadd Legacy	Pump, infusion	183	0
CADD legacy 1 pump	Pump, infusion	764	26
CADD Legacy PCA Pump	Pump, infusion, pca	199	68
CADD Legacy PCA Pumps	Pump, infusion, pca	41	109
CADD Legacy Plus Pump	Pump, infusion	793	587
Cadd Legacy Pump	Pump, infusion	865	4
CADD Medication Cassette	Set, administration, intravascular	90	120
CADD Medication Cassette Reservoir	Set, administration, intravascular	66	356
Cadd Medication Cassette Reservoirs With Flow Stop	Set, administration, intravascular	41	0
Cadd Ms3	Pump, infusion	166	0
Cadd Ms3 Pump	Pump, infusion	486	0
CADD Pump	Pump, infusion	70	29
CADD Solis Ambulatory Infusion Pump	Pump, infusion, pca	44	24
Cadd Solis Hpca Ambulatory Infusion Pump	Pump, infusion, pca	220	0
CADD Solis HPCA Pump	Pump, infusion, pca	1,172	1,177
CADD Solis HPCA Pumps	Pump, infusion, pca	32	154
CADD Solis Pump	Pump, infusion	16	55
Cadd Solis Vip	Pump, infusion	276	7
Cadd Solis Vip Ambulatory Infusion Pump	Pump, infusion	1,003	8
CADD Solis VIP Pump	Pump, infusion	2,691	238
Cadd Solis Vip Pumps	Pump, infusion	240	0
Cadd Solis Vip Pumps - 2120	Pump, infusion	79	0
Cadd-Legacy Duodopa Ambulatory Infusion Pump	Pump, infusion, enteral	189	0
CADD-Legacy One Ambulatory Infusion Pump	Pump, infusion	752	157
Cadd-Legacy Pca Ambulatory Infusion Pump	Pump, infusion, pca	360	1
Cadd-Legacy Plus Ambulatory Infusion Pump	Pump, infusion	614	15
CADD-Legacy PLUS Pump	Pump, infusion	576	159
Cadd-Legacy Pump	Pump, infusion	149	0
CADD-Solis Ambulatory Infusion Pump	Pump, infusion, pca	1,418	135
CADD-Solis HCPA Pump	Pump, infusion, pca	655	42
CADD-Solis HPCA Ambulatory Infusion Pump	Pump, infusion, pca	37	79
CADD-Solis HPCA Pump	Pump, infusion, pca	354	206
CADD-Solis VIP Ambulatory Infusion Pump	Pump, infusion	6,374	3,240
Cadd-Solis Vip Pump	Pump, infusion	207	0
Cassette Medi Reservoir	Set, i.v. fluid transfer	569	32
CLEO 90 Infusion Set	Set, administration, intravascular	2,103	97
Hypodermic Needle-Pro With Needle Protection Device	Manometer, spinal-fluid	19	0
Jelco	Catheter, intravascular, therapeutic, short-term less than 30 days	99	33
Level 1	Warmer, thermal, infusion fluid	105	0
Level 1 Fast Flow Fluid Warmer	Warmer, blood, non-electromagnetic radiation	188	25
Level 1 Hotline Blood And Fluid Warmer	Warmer, thermal, infusion fluid	420	17
Level 1 Hotline Fluid Warmer	Warmer, thermal, infusion fluid	113	1
Level 1 Hotline Fluid Warmer 390	Warmer, thermal, infusion fluid	104	10
Level 1 Hotline Low Flow System	Warmer, thermal, infusion fluid	162	0
Medex	Set, administration, intravascular	37	7
Medfusion	Pump, infusion	219	0
Medfusion 3500 Pump	Pump, infusion	365	14
Medfusion 3500 Syringe Infusion Pump	Pump, infusion	61	57
Medfusion 3500 Syringe Pump	Pump, infusion	246	0
Medfusion 4000 Pump	Pump, infusion	782	134
Medfusion 4000 Syringe Infusion Pump	Pump, infusion	946	549
Medfusion 4000 Wireless Syringe Infusion Pump	Pump, infusion	9	0
Medfusion Pump	Pump, infusion	162	0
Medfusion Syringe Pump	Pump, infusion	433	0
Pneupac paraPAC plus	Ventilator, emergency, powered (resuscitator)	151	31
Pneupac Parapac Ventilator	Ventilator, emergency, powered (resuscitator)	51	0
Portex	Tube, tracheal (w/wo connector)	20	6
Portex Blue Line Ultra Tracheostomy Tube	Tube, tracheostomy (w/wo connector)	16	27
Portex Endotracheal Tube	Tube, tracheal (w/wo connector)	100	24
Portex Spinal Anesthesia Trays	Anesthesia conduction kit	240	0

Device types

The table has the 27 device types with 5 or more reports that give this manufacturer. The rows are in order of name.

FDA says:

MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on 2 Oct 2026.

Device types in the reports that give Smiths Medical Asd as the manufacturer, in order of name
Device type	Product code	Reports
Anesthesia conduction kit	CAZ	757
Arterial blood sampling kit	CBT	38
Catheter, conduction, anesthetic	BSO	12
Catheter, intravascular, therapeutic, short-term less than 30 days	FOZ	1,243
Catheter, urological	KOD	5
Circuit, breathing (w connector, adaptor, y piece)	CAI	143
Device, warming. blood and plasma	KZL	202
Filter, infusion line	FPB	18
Humidifier, respiratory gas, (direct patient interface)	BTT	7
Manometer, spinal-fluid	FMJ	96
Needle, hypodermic, single lumen	FMI	829
Pump, infusion	FRN	28,873
Pump, infusion, enteral	LZH	294
Pump, infusion, pca	MEA	5,365
Set, administration, intravascular	FPA	8,228
Set, i.v. fluid transfer	LHI	2,499
Stopcock, i.v. set	FMG	98
Syringe, piston	FMF	14
System, thermal regulating	DWJ	86
Transducer, blood-pressure, extravascular	DRS	155
Tube tracheostomy and tube cuff	JOH	4,615
Tube, tracheal (w/wo connector)	BTR	431
Tube, tracheostomy (w/wo connector)	BTO	545
Tubes, vials, systems, serum separators, blood collection	JKA	440
Ventilator, emergency, powered (resuscitator)	BTL	642
Warmer, blood, non-electromagnetic radiation	BSB	559
Warmer, thermal, infusion fluid	LGZ	2,050

Reports by month

Reports that give Smiths Medical Asd as the manufacturer, by month, five years to September 2026

FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.

Event type

Event type in the reports that give Smiths Medical Asd as the manufacturer
Event type	Reports	Share
Death	164	0.3%
Injury	5,548	9.3%
Malfunction	53,673	90.2%
Other	23	under 0.1%
Not given	76	0.1%

The event type is the classification that the reporter gave. FDA does not verify it.

Official pages

Medical Device Reporting (MDR): How to Report Medical Device ProblemsThe FDA page that tells how to report a problem with a medical device.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
Manufacturer and User Facility Device Experience (MAUDE) DatabaseThe search page of FDA for the device reports.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Smiths Medical Asd: medical device reports that give this manufacturer. https://reportedreactions.com/manufacturer/smiths-medical-asd/ Source: U.S. Food and Drug Administration, openFDA Device Adverse Event (MAUDE) files, release of 23 Oct 2026. Reports received through 30 Sep 2026.

Where the data come from

The counts come from the openFDA Device Adverse Event (MAUDE) bulk files, release of 23 Oct 2026. The files have the reports that FDA received through 30 Sep 2026. Brand names, generic names and manufacturer names are as written on the reports. The names of the product codes come from the device classification of FDA.

The site removes company suffixes (Inc., LLC, GmbH and similar) before it counts a manufacturer name. A name that reads as a person and not as an organisation is not published. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Does a large count say something about the manufacturer?

Not by itself. FDA says:

MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on 2 Oct 2026.

The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on 2 Oct 2026.

What event types do the reports record?

Death (164), injury (5,548), malfunction (53,673) and other (23). The event type is the classification that the reporter gave. FDA does not verify it.

Why can one company have more than one page?

The manufacturer field is free text on the report. This page counts the 59,484 reports with the name Smiths Medical Asd after the site removes company suffixes. A subsidiary, a plant or a different spelling is a separate name.

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