B. BRAUN MELSUNGEN AG

FDA MAUDE device safety record · 1993–2026

What the Data Shows About B. BRAUN MELSUNGEN AG

B. BRAUN MELSUNGEN AG is associated with 5,805 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1993 through 2026. Of the total, 64 are coded as death reports and 356 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for B. BRAUN MELSUNGEN AG should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 5,305 reports (91.4% of total). Patient-outcome categorizations are reported across 11 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 20 years of MAUDE data, with the peak single-year volume reaching 655 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

5,805
Total Reports
64
Death Reports
356
Injury Reports
20
Device Types

Event Types

Malfunction 5,305 (91.4%)
Injury 356 (6.1%)
Death 64 (1.1%)
49 (0.8%)
Other 31 (0.5%)

Patient Outcomes

4,785 (81.3%)
Other 713 (12.1%)
Required Intervention 135 (2.3%)
Death 76 (1.3%)
R 62 (1.1%)
Hospitalization 61 (1.0%)
O 21 (0.4%)
Life Threatening 19 (0.3%)
Disability 9 (0.2%)
H 4 (0.1%)
D 3 (0.1%)

Yearly Trend

93
1993: 1
05
2005: 1
06
2006: 6
07
2007: 4
11
2011: 96
12
2012: 240
13
2013: 655
14
2014: 607
15
2015: 570
16
2016: 643
17
2017: 267
18
2018: 288
19
2019: 582
20
2020: 286
21
2021: 250
22
2022: 246
23
2023: 311
24
2024: 357
25
2025: 356
26
2026: 39

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.