Device manufacturer, as written on reports

Bd: medical device reports filed with FDA

2,086 reports name it as the manufacturer of the device involved, 2000–2025.

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.

2,086
reports naming it as manufacturer: 0% of all MAUDE reports; 4
reports, 12 months to August 2026: 64 in the 12 months before; 54%
classified as malfunction: 62.3% across all reports; 0.5%
classified as death, as reported: 0.9% across all reports

2,086 medical device reports received by FDA give Bd as the manufacturer of the device involved, 0% of the MAUDE database, from August 2000 to October 2025. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

4 reports arrived in the 12 months to August 2026, down 94% from 64 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 (54%), injury (36.4%) and other (6.1%). 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
Bd	Syringe, piston	79	0	1%
BD Insyte Autoguard	Catheter, intravascular, therapeutic, short-term less than 30 days	23	55	0%
Insyte AUTOGUARD	Catheter, intravascular, therapeutic, short-term less than 30 days	22	1,050	0%
BD alaris pump infusion set	Set, administration, intravascular	14	55	1.1%
BD Nexiva	Catheter, intravascular, therapeutic, short-term less than 30 days	13	14	0%
Nexiva	Catheter, intravascular, therapeutic, short-term less than 30 days	13	304	0%
Bd Ultra Fine Pen Needle	Needle, hypodermic, single lumen	11	0	0%
Bd Plastipak Syringes	Syringe, piston	5	0	0.5%
Bd Safetyglide Needle	Needle, hypodermic, single lumen	5	3	0%
BD Vacutainer Eclipse Blood Collection Needle	Needle, hypodermic, single lumen	5	627	0%
Alaris, SmartSite	Set, administration, intravascular	4	316	0.1%
Bd Insulin Syringe With Bd Ultra-Fine Needle	Syringe, piston	4	0	0%
Bd Precisionglide Needle	Needle, hypodermic, single lumen	4	0	0%
Bd Luer-Lok Tip Syringe	Syringe, piston	3	0	0%
BD Vacutainer Push Button Blood Collection Set	Tubes, vials, systems, serum separators, blood collection	3	324	0%
Alaris	Pump, infusion	2	79	1.1%
BD Syringe	Syringe, piston	2	117	0.4%
Eclipse	System, planning, radiation therapy treatment	2	44	0.7%
Luer-Lok	Syringe, piston	2	256	0%
Relion Insulin Syringe	Syringe, piston	2	0	0%
Smartsite Extension Set	Set, administration, intravascular	2	0	0.3%
Alaris Pca Module	Pump, infusion	1	0	3.1%
Bd 60ml Syringe Luer-Lok Tip	Syringe, piston	1	0	0%
Bd Eclipse Needle	Needle, hypodermic, single lumen	1	1	0%
Bd Insyte	Catheter, intravascular, therapeutic, short-term less than 30 days	1	0	0%
First Picc	Catheter, intravascular, therapeutic, short-term less than 30 days	1	0	0.4%

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
FMI	Needle, hypodermic, single lumen	545	26.1%
FMF	Syringe, piston	493	23.6%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	461	22.1%
FPA	Set, administration, intravascular	195	9.3%
JKA	Tubes, vials, systems, serum separators, blood collection	155	7.4%
QKP	Coronavirus antigen detection test system.	63	3%
NGT	Saline, vascular access flush	51	2.4%
GES	Blade, scalpel	38	1.8%
FMG	Stopcock, i.v. set	35	1.7%
LJS	Catheter, intravascular, therapeutic, long-term greater than 30 days	33	1.6%

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

Death0.5%11

Injury36.4%760

Malfunction54%1,126

Other6.1%127

Not given3%62

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

Questions about Bd reports

How many FDA device reports name Bd as manufacturer?

2,086 reports through August 2026, 4 of them in the latest 12 months.

Which of its brands appear most often?

Bd (79), BD Insyte Autoguard (23), Insyte AUTOGUARD (22), BD alaris pump infusion set (14) and BD Nexiva (13).

Which device types does it report on?

needle, hypodermic, single lumen (26.1%), syringe, piston (23.6%), catheter, intravascular, therapeutic, short-term less than 30 days (22.1%) and set, administration, intravascular (9.3%).

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.