Device manufacturer, as written on reports

Bd Caribe: medical device reports filed with FDA

1,366 reports name it as the manufacturer of the device involved, 2006–2026.

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.

1,366
reports naming it as manufacturer: 0% of all MAUDE reports; 72
reports, 12 months to August 2026: 157 in the 12 months before; 94.1%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

1,366 medical device reports received by FDA give Bd Caribe as the manufacturer of the device involved, 0% of the MAUDE database, from June 2006 to July 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

72 reports arrived in the 12 months to August 2026, down 54% from 157 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 (94.1%), injury (5.5%) and other (0.3%). 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 Microtainer Tubes with K2E (K2EDTA)	Tubes, vials, systems, serum separators, blood collection	210	43	0%
BD MiniDraw H&H Capillary Blood Collection Tube	Tubes, vacuum sample, with anticoagulant	95	76	0%
BD BACTEC Plus Aerobic/F Culture Vials (plastic)	System, blood culturing	45	82	0.1%
BD BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)	System, blood culturing	14	99	0.1%
Bd Bactec Peds Plus / F Culture Vials Plastic	System, blood culturing	14	79	0%
BD BACTEC Plus Anaerobic/F Culture Vials (plastic)	System, blood culturing	9	99	0%
Bd Microtainer Contact-Activated Lancet	Single use only blood lancet with an integral sharps injury prevention feature	1	10	0%
BD Vacutainer K2 EDTA (K2E) 10.8mg Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	1	25	0%
BD Vacutainer Serum Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	1	119	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	973	71.2%
GIM	Tubes, vacuum sample, with anticoagulant	113	8.3%
BSP	Needle, conduction, anesthetic (w/wo introducer)	91	6.7%
MDB	System, blood culturing	90	6.6%
CAZ	Anesthesia conduction kit	20	1.5%
FMK	Single use only blood lancet with an integral sharps injury prevention feature	20	1.5%
FMI	Needle, hypodermic, single lumen	8	0.6%
LFZ	Enzyme linked immunoabsorbent assay, cytomegalovirus	8	0.6%
MDM	Instrument, manual, surgical, general use	4	0.3%
GKZ	Counter, differential cell	3	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

Death0.1%1

Injury5.5%75

Malfunction94.1%1,286

Other0.3%4

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 Bd Caribe reports

How many FDA device reports name Bd Caribe as manufacturer?

1,366 reports through August 2026, 72 of them in the latest 12 months.

Which of its brands appear most often?

BD Microtainer Tubes with K2E (K2EDTA) (210), BD MiniDraw H&H Capillary Blood Collection Tube (95), BD BACTEC Plus Aerobic/F Culture Vials (plastic) (45), BD BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) (14) and Bd Bactec Peds Plus / F Culture Vials Plastic (14).

Which device types does it report on?

tubes, vials, systems, serum separators, blood collection (71.2%), tubes, vacuum sample, with anticoagulant (8.3%), needle, conduction, anesthetic (w/wo introducer) (6.7%) and system, blood culturing (6.6%).

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.