Device manufacturer, as written on reports

B Braun Melsungen: medical device reports filed with FDA

8,326 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.

8,326
reports naming it as manufacturer: 0% of all MAUDE reports; 738
reports, 12 months to August 2026: 729 in the 12 months before; 91.9%
classified as malfunction: 62.3% across all reports; 1.2%
classified as death, as reported: 0.9% across all reports

8,326 medical device reports received by FDA give B Braun Melsungen as the manufacturer of the device involved, 0% of the MAUDE database, from February 2006 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

738 reports arrived in the 12 months to August 2026, close to the 729 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 (91.9%), injury (5.8%) and death (1.2%). 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
Infusomat	Set, administration, intravascular	1,726	543	1.5%
Infusomat Space	Pump, infusion	1,231	12	0.2%
Introcan Safety	Catheter, intravascular, therapeutic, short-term less than 30 days	788	45	0.1%
Easypump	Pump, infusion, elastomeric	581	90	0.1%
Infusomat Space - Us Version	Pump, infusion	560	0	0.2%
Perfusor	Pump, infusion	451	115	7.5%
Perfusor Space	Pump, infusion	416	8	2.1%
Perifix	Epidural anesthesia kit	265	42	0%
Easypump 2	Pump, infusion, elastomeric	167	14	0%
Pencan	—	73	17	0%
B Braun	Set, i.v. fluid transfer	32	12	3%
Pump Infusion	Pump, infusion	25	5	0%
Pinnacle	Impactor	2	499	0.1%
Braun	Continuous measurement thermometer	1	24	0.5%
Collect No Qas Spine Anterior Stabilis	Appliance, fixation, spinal intervertebral body	1	0	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
FRN	Pump, infusion	4,717	56.7%
MEB	Pump, infusion, elastomeric	1,613	19.4%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	830	10%
OGE	Epidural anesthesia kit	207	2.5%
FPA	Set, administration, intravascular	164	2%
DQR	Cannula, catheter	162	1.9%
MEA	Pump, infusion, pca	125	1.5%
DYB	Introducer, catheter	103	1.2%
FMF	Syringe, piston	82	1%
BSO	Catheter, conduction, anesthetic	69	0.8%

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

Death1.2%102

Injury5.8%484

Malfunction91.9%7,654

Other0.4%33

Not given0.6%53

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 Melsungen reports

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

8,326 reports through August 2026, 738 of them in the latest 12 months.

Which of its brands appear most often?

Infusomat (1,726), Infusomat Space (1,231), Introcan Safety (788), Easypump (581) and Infusomat Space - Us Version (560).

Which device types does it report on?

pump, infusion (56.7%), pump, infusion, elastomeric (19.4%), catheter, intravascular, therapeutic, short-term less than 30 days (10%) and epidural anesthesia kit (2.5%).

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.