Device manufacturer, as written on reports

Becton Dickinson & Franklin Lakes: medical device reports filed with FDA

4,401 reports name it as the manufacturer of the device involved, 2025–2026.

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.

4,401
reports naming it as manufacturer: 0% of all MAUDE reports; 4,401
reports, 12 months to August 2026: 0 in the 12 months before; 98.4%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

4,401 medical device reports received by FDA give Becton Dickinson & Franklin Lakes as the manufacturer of the device involved, 0% of the MAUDE database, from October 2025 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

4,401 reports arrived in the 12 months to August 2026, with none 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 (98.4%) and injury (1.6%). 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 Vacutainer Eclipse Blood Collection Needle	Needle, hypodermic, single lumen	550	627	0%
BD Vacutainer SST Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	547	702	0%
BD Vacutainer UltraTouch Push Button Blood Collection Set	Set, administration, intravascular	416	581	0%
BD Vacutainer SST	Tubes, vials, systems, serum separators, blood collection	346	760	0%
BD Vacutainer Push Button Blood Collection Set	Tubes, vials, systems, serum separators, blood collection	234	324	0%
BD Vacutainer Buffered Sodium Citrate (9NC) Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	156	211	0%
BD Vacutainer Safety-Lok Blood Collection Set	Tubes, vials, systems, serum separators, blood collection	131	144	0%
BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	113	173	0%
BD Vacutainer UltraTouch Push Button Blood Collection Set with PAH	Set, administration, intravascular	108	120	0%
BD Vacutainer One Use Holder	Tubes, vials, systems, serum separators, blood collection	105	112	0%
BD Vacutainer Serum Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	86	119	0%
BD Vacutainer Serum	Tubes, vials, systems, serum separators, blood collection	75	121	0%
BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tubes	Tubes, vacuum sample, with anticoagulant	68	103	0%
BD MiniDraw H&H Capillary Blood Collection Tube	Tubes, vacuum sample, with anticoagulant	59	76	0%
BD Vacutainer K2 EDTA (K2E) 7.2mg Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	45	103	0%
BD Vacutainer Multiple Sample Luer Adapter	Tubes, vials, systems, serum separators, blood collection	42	52	0%
BD Microtainer Tubes with K2E (K2EDTA)	Tubes, vials, systems, serum separators, blood collection	37	43	0%
Bd Vacutainer Urine Analysis Preservative Tube	—	29	37	0%
BD Vacutainer PST Gel and Lithium HeparinN 56 Units	Tubes, vials, systems, serum separators, blood collection	28	55	0%
BD Vacutainer 9NC 0.109M Plus Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	27	85	0%
BD Vacutainer CPT Cell Preparation Tube with Sodium Citrate	Tubes, vials, systems, serum separators, blood collection	24	35	0%
BD Vacutainer PPT Plasma Preparation Tube K2E 9.0 mg	Blood/plasma collection device for dna testing	24	56	0%
BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	22	33	0%
BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder	Tubes, vials, systems, serum separators, blood collection	19	124	0%
Unspecified Bd Vacutainer Tube	Tubes, vials, systems, serum separators, blood collection	10	50	0%
BD Vacutainer EDTA 2K	Tubes, vials, systems, serum separators, blood collection	9	53	0.1%
Bd Vacutainer Brand Pronto Quick Release Needle Holder	Tubes, vials, systems, serum separators, blood collection	8	34	0%
Bd Microtainer Contact-Activated Lancet	Single use only blood lancet with an integral sharps injury prevention feature	5	10	0%
Bd Vacutainer Cpt Cell Preparation Tube With Sodium Heparin	Tubes, vials, systems, serum separators, blood collection	5	27	0%
BD Vacutainer 9NC 0.109M 2.7 mL	Tubes, vials, systems, serum separators, blood collection	4	79	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
JKA	Tubes, vials, systems, serum separators, blood collection	3,043	69.1%
FPA	Set, administration, intravascular	776	17.6%
GIM	Tubes, vacuum sample, with anticoagulant	326	7.4%
FMH	Container, specimen, sterile	76	1.7%
FMI	Needle, hypodermic, single lumen	59	1.3%
PJE	Blood/plasma collection device for dna testing	21	0.5%
JSM	Culture media, non-propagating transport	13	0.3%
FMK	Single use only blood lancet with an integral sharps injury prevention feature	9	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%0

Injury1.6%71

Malfunction98.4%4,330

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 Becton Dickinson & Franklin Lakes reports

How many FDA device reports name Becton Dickinson & Franklin Lakes as manufacturer?

4,401 reports through August 2026, 4,401 of them in the latest 12 months.

Which of its brands appear most often?

BD Vacutainer Eclipse Blood Collection Needle (550), BD Vacutainer SST Blood Collection Tubes (547), BD Vacutainer UltraTouch Push Button Blood Collection Set (416), BD Vacutainer SST (346) and BD Vacutainer Push Button Blood Collection Set (234).

Which device types does it report on?

tubes, vials, systems, serum separators, blood collection (69.1%), set, administration, intravascular (17.6%), tubes, vacuum sample, with anticoagulant (7.4%) and container, specimen, sterile (1.7%).

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.