Device manufacturer, as written on reports

Becton Dickinson And Bd: medical device reports filed with FDA

16,957 reports name it as the manufacturer of the device involved, 2016–2026.

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.

16,957
reports naming it as manufacturer: 0.1% of all MAUDE reports; 1,874
reports, 12 months to August 2026: 2,340 in the 12 months before; 99.2%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

16,957 medical device reports received by FDA give Becton Dickinson And Bd as the manufacturer of the device involved, 0.1% of the MAUDE database, from April 2016 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,874 reports arrived in the 12 months to August 2026, down 20% from 2,340 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 (99.2%) and injury (0.8%). 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 Preset Arterial Blood Collection Syringe	Tubes, vials, systems, serum separators, blood collection	977	11	0%
BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder	Tubes, vials, systems, serum separators, blood collection	679	124	0%
BD Vacutainer K2E 3.6mg Plus Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	459	90	0%
BD Preset Eclipse	Tubes, vials, systems, serum separators, blood collection	413	33	0%
BD Vacutainer 9NC 0.109M Plus Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	397	85	0%
Bd Preset Syringe With Attached Needle	Tubes, vials, systems, serum separators, blood collection	366	0	0%
Bd Vacutainer Precisionglide Multiple Sample Needle	Tubes, vials, systems, serum separators, blood collection	351	0	0%
BD Vacutainer UltraTouch Push Button Blood Collection Set	Set, administration, intravascular	350	581	0%
BD Vacutainer K2E 10.8mg Plus Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	322	36	0%
BD Vacutainer 9NC 0.109M Buffered Trisodium Citrate Plus Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	312	19	0%
Bd Vacutainer K2e Edta 7 2mg Plus Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	253	17	0%
BD Vacutainer K2E 5.4mg Plus Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	224	74	0%
BD Vacutainer Push Button Blood Collection Set	Tubes, vials, systems, serum separators, blood collection	219	324	0%
BD Vacutainer CAT (Clot Activator Tube) Plus Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	214	9	0%
Bd Vacutainer Barricor Lh Plasma Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	187	0	0%
BD Vacutainer K3E 5.4mg Plus Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	183	23	0%
BD Vacutainer K2E (EDTA) 10.8mg Plus Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	169	16	0%
BD Vacutainer 9NC 0.109M 2.7 mL	Tubes, vials, systems, serum separators, blood collection	168	79	0%
Bd Vacutainer Eclipse Signal Blood Collection Needle	Tubes, vials, systems, serum separators, blood collection	131	8	0%
PAXgene Blood RNA Tube	—	117	9	0%
Bd Vacutainer K2 Edta K2e Plus Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	99	15	0%
BD Vacutainer Blood Collection Tubes Buffered Sodium Citrate 0.3mL - 0.109M	Tubes, vials, systems, serum separators, blood collection	90	6	0%
Bd Vacutainer 9nc 0 129m Plus Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	59	12	0%
Bd Vacutainer Urine Analysis Preservative Tube	—	5	37	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	15,459	91.2%
FMI	Needle, hypodermic, single lumen	590	3.5%
FPA	Set, administration, intravascular	356	2.1%
FMF	Syringe, piston	74	0.4%
FMH	Container, specimen, sterile	68	0.4%
GIM	Tubes, vacuum sample, with anticoagulant	67	0.4%
PJE	Blood/plasma collection device for dna testing	53	0.3%
JSM	Culture media, non-propagating transport	37	0.2%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	4	0%
LHI	Set, i.v. fluid transfer	3	0%

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

Injury0.8%133

Malfunction99.2%16,823

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 And Bd reports

How many FDA device reports name Becton Dickinson And Bd as manufacturer?

16,957 reports through August 2026, 1,874 of them in the latest 12 months.

Which of its brands appear most often?

Bd Preset Arterial Blood Collection Syringe (977), BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder (679), BD Vacutainer K2E 3.6mg Plus Blood Collection Tubes (459), BD Preset Eclipse (413) and BD Vacutainer 9NC 0.109M Plus Blood Collection Tubes (397).

Which device types does it report on?

tubes, vials, systems, serum separators, blood collection (91.2%), needle, hypodermic, single lumen (3.5%), set, administration, intravascular (2.1%) and syringe, piston (0.4%).

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.