Device manufacturer, as written on reports

Becton Dickinson: medical device reports filed with FDA

44,307 reports name it as the manufacturer of the device involved, 1992–2026.

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.

44,307
reports naming it as manufacturer: 0.2% of all MAUDE reports; 5,236
reports, 12 months to August 2026: 4,235 in the 12 months before; 88.2%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

44,307 medical device reports received by FDA give Becton Dickinson as the manufacturer of the device involved, 0.2% of the MAUDE database, from January 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

5,236 reports arrived in the 12 months to August 2026, up 24% from 4,235 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 (88.2%), injury (7.8%) and other (3.7%). 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
Plate Columbia Ag 5% Sb 90mm 20	Culture media, enriched	2,496	2,496	0%
Unspecified Bd Pen Needle	Needle, hypodermic, single lumen	1,794	0	0.1%
Bd Paradigm Link Blood Glucose Monitor	System, test, blood glucose, over the counter	1,166	0	0.1%
Unspecified Bd Syringe	Syringe, piston	852	0	0.1%
BD BBL Columbia Agar with 5% Sheep Blood	Lectins and protectins	705	709	0%
BD Vacutainer Safety-Lok Blood Collection Set	Tubes, vials, systems, serum separators, blood collection	614	144	0%
Syringe 50ml Ll	Syringe, piston	440	23	0%
BD Vacutainer Buffered Sodium Citrate (9NC) Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	436	211	0%
Bd Plastipak Concentric Luer Lock Syringe	Syringe, piston	408	0	0.2%
BD Vacutainer EDTA 2K	Tubes, vials, systems, serum separators, blood collection	309	53	0.1%
Unspecified BD Infusion Set	Set, administration, intravascular	305	484	0.2%
Bd Logic Blood Glucose Monitor	System, test, blood glucose, over the counter	301	0	0%
Unspecified Bd Needle	Needle, hypodermic, single lumen	301	0	0%
Unspecified Bd Lihep No Gel Collection Tube	Tubes, vials, systems, serum separators, blood collection	277	0	0%
BD Syringe	Syringe, piston	249	117	0.4%
Bd Vacutainer Pst Gel And Lithium Heparinn Lh Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	246	2	0%
Unspecified Bd Introsyte Introducer	Introducer, catheter	219	0	0%
BD Vacutainer K2 EDTA (K2E) 7.2mg Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	203	103	0%
Unspecified Bd Catheter	Catheter, intravascular, therapeutic, short-term less than 30 days	194	0	0%
BD Vacutainer Rapid Serum Tube (RST) Blood Collection Tubes Thrombin	Tubes, vials, systems, serum separators, blood collection	185	13	0%
Bd Plastipak Syringe	Syringe, piston	181	25	0%
Needle Filter Blunt Fill 18x1-1/2	Needle, aspiration and injection, disposable	161	49	0%
Bd Plastipak 50ml Concentric Luer Lock Syringe	Syringe, piston	158	0	0.5%
Syringe 50ml Ll Tip 1ml	Syringe, piston	156	10	0%
Bd Microtainer Contact-Activated Lancet	Single use only blood lancet with an integral sharps injury prevention feature	152	10	0%
Needle 18x1-1/2 Blunt Fill	Needle, aspiration and injection, disposable	144	18	0%
Bd Plastipak Luer-Lok Syringe	Syringe, piston	143	0	0%
Bd Vacutainer K2 Edta K2e Plus Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	143	15	0%
Bd Plastipak Syringes	Syringe, piston	136	0	0.5%
BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	133	173	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	9,574	21.6%
JKA	Tubes, vials, systems, serum separators, blood collection	7,766	17.5%
FMI	Needle, hypodermic, single lumen	7,446	16.8%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	3,435	7.8%
ONB	Closed antineoplastic and hazardous drug reconstitution and transfer system	2,817	6.4%
FPA	Set, administration, intravascular	2,649	6%
KZI	Culture media, enriched	2,580	5.8%
NBW	System, test, blood glucose, over the counter	1,729	3.9%
KSI	Lectins and protectins	700	1.6%
GAA	Needle, aspiration and injection, disposable	402	0.9%

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%49

Injury7.8%3,453

Malfunction88.2%39,059

Other3.7%1,637

Not given0.2%109

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

Questions about Becton Dickinson reports

How many FDA device reports name Becton Dickinson as manufacturer?

44,307 reports through August 2026, 5,236 of them in the latest 12 months.

Which of its brands appear most often?

Plate Columbia Ag 5% Sb 90mm 20 (2,496), Unspecified Bd Pen Needle (1,794), Bd Paradigm Link Blood Glucose Monitor (1,166), Unspecified Bd Syringe (852) and BD BBL Columbia Agar with 5% Sheep Blood (705).

Which device types does it report on?

syringe, piston (21.6%), tubes, vials, systems, serum separators, blood collection (17.5%), needle, hypodermic, single lumen (16.8%) and catheter, intravascular, therapeutic, short-term less than 30 days (7.8%).

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.