Device manufacturer, as written on reports

Bd Medical Bd West Medical Surgical: medical device reports filed with FDA

6,884 reports name it as the manufacturer of the device involved, 2015–2026.

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.

6,884
reports naming it as manufacturer: 0% of all MAUDE reports; 661
reports, 12 months to August 2026: 3 in the 12 months before; 96.7%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

6,884 medical device reports received by FDA give Bd Medical Bd West Medical Surgical as the manufacturer of the device involved, 0% of the MAUDE database, from September 2015 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

661 reports arrived in the 12 months to August 2026, up 21933% from 3 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 (96.7%), injury (3.3%) and death (0.1%). 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 Precisionglide Needle	Needle, hypodermic, single lumen	799	0	0%
Bd Posiflush Normal Saline Syringe	Saline, vascular access flush	455	0	0%
Bd Luer-Lok Tip Syringe	Syringe, piston	375	0	0%
Bd Luer-Lok Syringe	Syringe, piston	234	0	0%
10 Ml Bd Posiflush Normal Saline Syringe	Saline, vascular access flush	195	0	0%
Bd Posiflush Syringe	Saline, vascular access flush	171	0	0.5%
Bd Syringe With Bd Luer-Lok Tip	Syringe, piston	164	0	0%
Bd 60ml Syringe Luer-Lok Tip	Syringe, piston	113	0	0%
Bd Blunt Fill Needle	Needle, aspiration and injection, disposable	113	1	0%
Luer-Lok	Syringe, piston	106	256	0%
Syringe 5ml Saline Fill China Sp	Saline, vascular access flush	97	23	0%
Syringe 10ml Reg Pr Saline 10ml Fill	Saline, vascular access flush	78	0	0%
Needle Filter Blunt Fill 18x1-1/2	Needle, aspiration and injection, disposable	76	49	0%
BD Luer-Lok	Syringe, piston	70	333	0%
Syringe 10ml Saline Fill China Sp	Saline, vascular access flush	63	21	0%
Bd Safetyglide Needle	Needle, hypodermic, single lumen	58	3	0%
Needle 30x1/2 Rb	Needle, hypodermic, single lumen	52	0	0%
Bd Syringe Luer-Lok Tip	Syringe, piston	37	0	0%
Syringe 20ml Ll S/C 48	Syringe, piston	37	1	0%
Syringe 50ml Ll Tip 1ml	Syringe, piston	37	10	0%
Syringe 30ml Ll S/C 56	Syringe, piston	35	4	0%
Bd Safetyglide Needle Only 25 G	Needle, hypodermic, single lumen	18	0	0%
Needle 18x1-1/2 Blunt Fill	Needle, aspiration and injection, disposable	17	18	0%
Bd Luer-Lok Syringe Bulk Sterile Pharmacy Convenience Tray	Syringe, piston	5	0	0%
Bd Plastipak Syringes	Syringe, piston	5	0	0.5%
BD SafetyGlide	Needle, hypodermic, single lumen	1	127	0%

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
FMF	Syringe, piston	2,466	35.8%
FMI	Needle, hypodermic, single lumen	2,096	30.4%
NGT	Saline, vascular access flush	1,459	21.2%
GAA	Needle, aspiration and injection, disposable	594	8.6%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	101	1.5%
KYZ	Syringe, irrigating (non dental)	57	0.8%
NZW	Heparin, vascular access flush	35	0.5%
MEG	Syringe, antistick	33	0.5%
FPA	Set, administration, intravascular	18	0.3%
KNT	Tubes, gastrointestinal (and accessories)	15	0.2%

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

Death0.1%4

Injury3.3%225

Malfunction96.7%6,655

Other0%0

Not given0%0

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

Questions about Bd Medical Bd West Medical Surgical reports

How many FDA device reports name Bd Medical Bd West Medical Surgical as manufacturer?

6,884 reports through August 2026, 661 of them in the latest 12 months.

Which of its brands appear most often?

Bd Precisionglide Needle (799), Bd Posiflush Normal Saline Syringe (455), Bd Luer-Lok Tip Syringe (375), Bd Luer-Lok Syringe (234) and 10 Ml Bd Posiflush Normal Saline Syringe (195).

Which device types does it report on?

syringe, piston (35.8%), needle, hypodermic, single lumen (30.4%), saline, vascular access flush (21.2%) and needle, aspiration and injection, disposable (8.6%).

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.