Device manufacturer, as written on reports

B Braun Medical: medical device reports filed with FDA

12,488 reports name it as the manufacturer of the device involved, 1993–2026.

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.

12,488
reports naming it as manufacturer: 0.1% of all MAUDE reports; 1,880
reports, 12 months to August 2026: 1,903 in the 12 months before; 83.5%
classified as malfunction: 62.3% across all reports; 0.7%
classified as death, as reported: 0.9% across all reports

12,488 medical device reports received by FDA give B Braun Medical as the manufacturer of the device involved, 0.1% of the MAUDE database, from August 1993 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,880 reports arrived in the 12 months to August 2026, close to the 1,903 of 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 (83.5%), injury (8.8%) and other (6.2%). 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
Hemodialysis Bloodlines	Set, tubing, blood, with and without anti-regurgitation valve	2,327	1,135	0.4%
Infusomat	Set, administration, intravascular	2,084	543	1.5%
Caresite	Set, administration, intravascular	642	61	0.1%
Perifix	Epidural anesthesia kit	472	42	0%
Introcan Safety	Catheter, intravascular, therapeutic, short-term less than 30 days	439	45	0.1%
Outlook	Pump, infusion	194	0	1%
Safsite	Set, administration, intravascular	186	35	0%
B Braun	Set, i.v. fluid transfer	176	12	3%
Design Options	Epidural anesthesia kit	165	11	0%
Ultrasite	Set, administration, intravascular	163	9	0%
Outlook Es	Pump, infusion	157	0	2.5%
Pencan	—	105	17	0%
Extension Set	Set, administration, for peritoneal dialysis, disposable	68	66	1.3%
Apex	Catheters, transluminal coronary angioplasty, percutaneous	67	78	1.3%
Infusomat Space	Pump, infusion	62	12	0.2%
Blood Administration Set	Set, administration, intravascular	52	0	0.5%
Pinnacle	Impactor	48	499	0.1%
Celsite	Port & catheter, implanted, subcutaneous, intravascular	41	51	0.9%
Braun	Continuous measurement thermometer	29	24	0.5%
Perfusor Space	Pump, infusion	12	8	2.1%
Microbore Extension Set	Set, administration, intravascular	4	0	0%
Easypump 2	Pump, infusion, elastomeric	3	14	0%
Easypump	Pump, infusion, elastomeric	2	90	0.1%
Attain	Permanent pacemaker electrode	1	0	1.5%
Catheter	Pump, infusion, implanted, programmable	1	9	3.7%

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
FPA	Set, administration, intravascular	5,006	40.1%
FJK	Set, tubing, blood, with and without anti-regurgitation valve	2,450	19.6%
FRN	Pump, infusion	1,126	9%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	537	4.3%
OGE	Epidural anesthesia kit	492	3.9%
CAZ	Anesthesia conduction kit	470	3.8%
LHI	Set, i.v. fluid transfer	381	3.1%
FMI	Needle, hypodermic, single lumen	121	1%
BSO	Catheter, conduction, anesthetic	94	0.8%
DXT	Injector and syringe, angiographic	85	0.7%

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

Death0.7%82

Injury8.8%1,105

Malfunction83.5%10,428

Other6.2%771

Not given0.8%102

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about B Braun Medical reports

How many FDA device reports name B Braun Medical as manufacturer?

12,488 reports through August 2026, 1,880 of them in the latest 12 months.

Which of its brands appear most often?

Hemodialysis Bloodlines (2,327), Infusomat (2,084), Caresite (642), Perifix (472) and Introcan Safety (439).

Which device types does it report on?

set, administration, intravascular (40.1%), set, tubing, blood, with and without anti-regurgitation valve (19.6%), pump, infusion (9%) and catheter, intravascular, therapeutic, short-term less than 30 days (4.3%).

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.