Device manufacturer, as written on reports

Becton Dickinson & Broken Bow: medical device reports filed with FDA

9,914 reports name it as the manufacturer of the device involved, 2019–2025.

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.

9,914
reports naming it as manufacturer: 0% of all MAUDE reports; 426
reports, 12 months to August 2026: 1,778 in the 12 months before; 99.3%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

9,914 medical device reports received by FDA give Becton Dickinson & Broken Bow as the manufacturer of the device involved, 0% of the MAUDE database, from March 2019 to December 2025. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

426 reports arrived in the 12 months to August 2026, down 76% from 1,778 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 (99.3%) and injury (0.7%). 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
BD Vacutainer Buffered Sodium Citrate (9NC) Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	924	211	0%
Bd Vacutainer Buffered Sodium Citrate 9nc Blood Collection Tube	Tubes, vials, systems, serum separators, blood collection	783	1	0%
BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	743	173	0%
BD Vacutainer EDTA 2K	Tubes, vials, systems, serum separators, blood collection	679	53	0.1%
BD Vacutainer K2 EDTA (K2E) 7.2mg Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	492	103	0%
BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tubes	Tubes, vacuum sample, with anticoagulant	433	103	0%
Bd Vacutainer Pst Gel And Lithium Heparinn Lh Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	388	2	0%
BD Vacutainer PPT Plasma Preparation Tube K2E 9.0 mg	Blood/plasma collection device for dna testing	374	56	0%
BD Vacutainer CPT Cell Preparation Tube with Sodium Citrate	Tubes, vials, systems, serum separators, blood collection	244	35	0%
BD Vacutainer K2 EDTA (K2E) 10.8mg Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	189	25	0%
BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	177	33	0%
Bd Vacutainer Cpt Cell Preparation Tube With Sodium Heparin	Tubes, vials, systems, serum separators, blood collection	173	27	0%
Bd Vacutainer K2 Edta K2e Plus Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	170	15	0%
Bd Vacutainer 9nc 0 129m Plus Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	161	12	0%
Bd Vacutainer Ppt Plasma Preparation Tubes K2e Edta 9 0 Mg	Blood/plasma collection device for dna testing	149	1	0%
BD Vacutainer PST Gel and Lithium HeparinN 56 Units	Tubes, vials, systems, serum separators, blood collection	127	55	0%
Bd Vacutainer K2 Edta K2e Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	87	0	0%
Bd Vacutainer Urine Analysis Preservative Tube	—	63	37	0%
BD Vacutainer One Use Holder	Tubes, vials, systems, serum separators, blood collection	46	112	0%
BD Vacutainer Serum Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	39	119	0%
BD Vacutainer Blood Collection Tubes Buffered Sodium Citrate 0.3mL - 0.109M	Tubes, vials, systems, serum separators, blood collection	27	6	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	7,858	79.3%
GIM	Tubes, vacuum sample, with anticoagulant	857	8.6%
PJE	Blood/plasma collection device for dna testing	489	4.9%
JSM	Culture media, non-propagating transport	203	2%
FMH	Container, specimen, sterile	104	1%
FMF	Syringe, piston	1	0%
FMI	Needle, hypodermic, single lumen	1	0%
FPA	Set, administration, intravascular	1	0%
NGT	Saline, vascular access flush	1	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%0

Injury0.7%74

Malfunction99.3%9,840

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 & Broken Bow reports

How many FDA device reports name Becton Dickinson & Broken Bow as manufacturer?

9,914 reports through August 2026, 426 of them in the latest 12 months.

Which of its brands appear most often?

BD Vacutainer Buffered Sodium Citrate (9NC) Blood Collection Tubes (924), Bd Vacutainer Buffered Sodium Citrate 9nc Blood Collection Tube (783), BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes (743), BD Vacutainer EDTA 2K (679) and BD Vacutainer K2 EDTA (K2E) 7.2mg Blood Collection Tubes (492).

Which device types does it report on?

tubes, vials, systems, serum separators, blood collection (79.3%), tubes, vacuum sample, with anticoagulant (8.6%), blood/plasma collection device for dna testing (4.9%) and culture media, non-propagating transport (2%).

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.