Device manufacturer, as written on reports

Smiths Medical International: medical device reports filed with FDA

5,088 reports name it as the manufacturer of the device involved, 2004–2025.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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." And: "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."

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.

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

5,088
reports naming it as manufacturer: 0% of all MAUDE reports; 9
reports, 12 months to August 2026: 55 in the 12 months before; 85.4%
classified as malfunction: 62.3% across all reports; 0.9%
classified as death, as reported: 0.9% across all reports

5,088 medical device reports received by FDA give Smiths Medical International as the manufacturer of the device involved, 0% of the MAUDE database, from August 2004 to November 2025. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

9 reports arrived in the 12 months to August 2026, down 84% from 55 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (85.4%), injury (13.6%) and death (0.9%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Portex	Tube, tracheal (w/wo connector)	518	8	0.6%
Pneupac paraPAC plus	Ventilator, emergency, powered (resuscitator)	372	37	0%
Portex General Anesthesia Circuits	Circuit, breathing (w connector, adaptor, y piece)	238	10	0%
Pneupac Ventilators Parapac Plus	Ventilator, emergency, powered (resuscitator)	172	0	1%
Portex Anesthesia Breathing Circuit	Circuit, breathing (w connector, adaptor, y piece)	140	4	0%
Portex Endotracheal Tubes	Tube, tracheal (w/wo connector)	117	36	0.4%
Portex Blue Line Ultra Tracheostomy Tube	Tube, tracheostomy (w/wo connector)	114	30	0%
Portex Endotracheal Tube	Tube, tracheal (w/wo connector)	75	25	0%
Pneupac	Ventilator, emergency, powered (resuscitator)	63	0	0%
Portex Tracheal Tube Clear Murphey Eyesoft Seal	Tube, tracheal (w/wo connector)	44	118	0.4%
Pneupac Parapac Ventilator	Ventilator, emergency, powered (resuscitator)	39	0	0.4%
Portex Tubes BLUselect Suctionaid	Tube, tracheostomy (w/wo connector)	17	72	0.6%
CADD Solis HPCA Pump	Pump, infusion, pca	8	1,183	0.1%
CADD-Solis Ambulatory Infusion Pump	Pump, infusion, pca	8	151	0.3%
CADD Legacy PCA Pump	Pump, infusion, pca	5	71	0%
CADD-Solis VIP Ambulatory Infusion Pump	Pump, infusion	5	3,471	0.1%
Jelco	Catheter, intravascular, therapeutic, short-term less than 30 days	5	34	0%
CADD Solis HPCA Pumps	Pump, infusion, pca	3	145	0%
Cadd Solis Pump Kit	Pump, infusion, pca	3	0	0%
CADD Solis VIP Pump	Pump, infusion	3	235	0.1%
Medex	Set, administration, intravascular	3	8	0%
Bivona	Tube tracheostomy and tube cuff	2	11	1%
Cadd Administration Sets - Flow Stop	Set, administration, intravascular	1	26	0.3%
CADD legacy 1 pump	Pump, infusion	1	23	0.2%
CADD Legacy PCA Pumps	Pump, infusion, pca	1	116	0%
Cadd Solis Vip Pump Kit	Pump, infusion	1	0	0.5%
CADD-Solis HCPA Pump	Pump, infusion, pca	1	33	0%
Ni	Set, administration, for peritoneal dialysis, disposable	1	1,587	1.8%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
BTO	Tube, tracheostomy (w/wo connector)	1,414	27.8%
BTR	Tube, tracheal (w/wo connector)	1,116	21.9%
BTL	Ventilator, emergency, powered (resuscitator)	951	18.7%
JOH	Tube tracheostomy and tube cuff	549	10.8%
CAI	Circuit, breathing (w connector, adaptor, y piece)	383	7.5%
FRN	Pump, infusion	72	1.4%
CBI	Tube, tracheal/bronchial, differential ventilation (w/wo connector)	69	1.4%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	62	1.2%
DRS	Transducer, blood-pressure, extravascular	43	0.8%
CAZ	Anesthesia conduction kit	39	0.8%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.9%46

Injury13.6%692

Malfunction85.4%4,347

Other0%2

Not given0%1

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Smiths Medical International reports

How many FDA device reports name Smiths Medical International as manufacturer?

5,088 reports through August 2026, 9 of them in the latest 12 months.

Which of its brands appear most often?

Portex (518), Pneupac paraPAC plus (372), Portex General Anesthesia Circuits (238), Pneupac Ventilators Parapac Plus (172) and Portex Anesthesia Breathing Circuit (140).

Which device types does it report on?

tube, tracheostomy (w/wo connector) (27.8%), tube, tracheal (w/wo connector) (21.9%), ventilator, emergency, powered (resuscitator) (18.7%) and tube tracheostomy and tube cuff (10.8%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.