Device manufacturer, as written on reports

Becton Dickinson & Sparks: medical device reports filed with FDA

14,560 reports name it as the manufacturer of the device involved, 2020–2026.

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.

14,560
reports naming it as manufacturer: 0.1% of all MAUDE reports; 2,704
reports, 12 months to August 2026: 5,050 in the 12 months before; 99.5%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

14,560 medical device reports received by FDA give Becton Dickinson & Sparks as the manufacturer of the device involved, 0.1% of the MAUDE database, from September 2020 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

2,704 reports arrived in the 12 months to August 2026, down 46% from 5,050 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 (99.5%) and injury (0.5%). 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 BACTEC MGIT Mycobacteria Growth Indicator Tubes	System, blood culturing	1,224	108	0%
BD MAX System, BD MAX Instrument	Real time nucleic acid amplification system	1,059	252	0%
Bd Rapid Detection Of Sars-Cov-2 Veritor	Coronavirus antigen detection test system.	865	0	0%
BD BACTEC MGIT 960 PZA Kit	Susceptibility test powders, antimycobacterial	576	121	0%
BD Phoenix M50 Automated Microbiology System	System, test, automated, antimicrobial susceptibility, short incubation	463	143	0%
Bd Bactec Fx Instrument Top Packaged	System, blood culturing	444	0	0.2%
Panel Phoenix NMIC/ID-307	System, test, automated, antimicrobial susceptibility, short incubation	429	10	0%
Bd Rapid Detection Of Sars-Cov-2 Veritor Assay	Coronavirus antigen detection test system.	376	0	0%
Bd Bbl Mgit Mycobacteria Growth Indicator Tubes 7ml	System, blood culturing	313	10	0%
Bd Bbl Sabouraud Dextrose Agar Emmons Deep Fill	Culture media, enriched	300	300	0%
Bd Bbl Phenylethyl Alcohol Agar With 5% Sheep Blood	Culture media, selective and non-differential	299	0	0%
Bd Veritor At-Home Covid-19 Test	Coronavirus antigen detection test system.	267	0	0%
Bd Sars-Cov-2 Reagents For Bd Max System	Reagents, 2019-novel coronavirus nucleic acid	261	0	0%
Bd Bbl Mycoprep- Specimen Digestion/Decontamination Kit 75 Ml	General purpose reagent	200	200	0%
Bd Bbl Columbia Agar With 5% Sheep Blood Plate 100pk	Culture media, enriched	199	0	0%
Bd Phoenix Ast Broth	System, test, automated, antimicrobial susceptibility, short incubation	190	25	0%
BD BACTEC MGIT 960 SIRE Kit	Susceptibility test powders, antimycobacterial	158	94	0%
BD Phoenix AP	—	158	20	0%
Bd Phoenix Pmic/Id-107	System, test, automated, antimicrobial susceptibility, short incubation	155	28	0%
BD BACTEC MGIT 960 Supplement Kit	System, blood culturing	148	71	0%
Bd Bbl Thioglycollate Medium Enriched With Vitamin K1 And Hemin	Culture media, non-selective and non-differential	143	0	0%
BD BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)	System, blood culturing	19	99	0.1%
BD BACTEC Plus Aerobic/F Culture Vials (plastic)	System, blood culturing	12	82	0.1%
Bd Affirm Vpiii Microbial Identification Test	—	5	3	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
MDB	System, blood culturing	2,775	19.1%
LON	System, test, automated, antimicrobial susceptibility, short incubation	2,267	15.6%
QKP	Coronavirus antigen detection test system.	1,521	10.4%
LXG	Equipment, laboratory, general purpose, labeled or promoted for a specific medical use	1,249	8.6%
OOI	Real time nucleic acid amplification system	1,189	8.2%
JSG	Culture media, non-selective and non-differential	867	6%
MJA	Susceptibility test powders, antimycobacterial	842	5.8%
KZI	Culture media, enriched	499	3.4%
QJR	Reagents, 2019-novel coronavirus nucleic acid	310	2.1%
JSJ	Culture media, selective and non-differential	302	2.1%

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

Injury0.5%72

Malfunction99.5%14,487

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 & Sparks reports

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

14,560 reports through August 2026, 2,704 of them in the latest 12 months.

Which of its brands appear most often?

BD BACTEC MGIT Mycobacteria Growth Indicator Tubes (1,224), BD MAX System, BD MAX Instrument (1,059), Bd Rapid Detection Of Sars-Cov-2 Veritor (865), BD BACTEC MGIT 960 PZA Kit (576) and BD Phoenix M50 Automated Microbiology System (463).

Which device types does it report on?

system, blood culturing (19.1%), system, test, automated, antimicrobial susceptibility, short incubation (15.6%), coronavirus antigen detection test system. (10.4%) and equipment, laboratory, general purpose, labeled or promoted for a specific medical use (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.