Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
15 linked reportsMalfunction 15
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.4 |
| 2019-03 | 0 | 4 |
| 2019-04 | 0 | 1.25 |
| 2019-05 | 0 | 1 |
| 2019-06 | 1 | 7.67 |
| 2019-07 | 1 | 2 |
| 2019-08 | 0 | 2 |
| 2019-09 | 4 | 2.17 |
| 2019-10 | 5 | 5 |
| 2019-11 | 0 | 2.5 |
| 2019-12 | 0 | 2.86 |
| 2020-01 | 0 | 2 |
| 2020-02 | 0 | 2 |
| 2020-03 | 0 | 2.43 |
| 2020-04 | 0 | 2.13 |
| 2020-05 | 0 | 1 |
| 2020-06 | 0 | 1 |
| 2020-07 | 0 | 1.25 |
| 2020-08 | 0 | 1 |
| 2020-09 | 0 | 1.25 |
| 2020-10 | 0 | 1.4 |
| 2020-11 | 0 | 1.67 |
| 2020-12 | 0 | 2 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 1.67 |
| 2021-03 | 0 | 2 |
| 2021-04 | 0 | 2.2 |
| 2021-05 | 0 | 1.44 |
| 2021-06 | 0 | 1.7 |
| 2021-07 | 0 | 2.56 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1.33 |
| 2021-10 | 0 | 1 |
| 2021-11 | 0 | 2.6 |
| 2021-12 | 0 | 1.33 |
| 2022-01 | 0 | 2 |
| 2022-02 | 0 | 1.67 |
| 2022-03 | 0 | 2.25 |
| 2022-04 | 0 | 2.67 |
| 2022-05 | 0 | 1.5 |
| 2022-06 | 0 | 2.43 |
| 2022-07 | 0 | 1.29 |
| 2022-08 | 0 | 1 |
| 2022-09 | 0 | 1.33 |
| 2022-10 | 0 | 1.4 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 1.33 |
| 2023-01 | 0 | 1 |
| 2023-02 | 0 | 2.25 |
| 2023-03 | 0 | 2.44 |
| 2023-04 | 0 | 1.67 |
| 2023-05 | 0 | 1 |
| 2023-06 | 0 | 1.25 |
| 2023-07 | 0 | 1.5 |
| 2023-08 | 0 | 1 |
| 2023-09 | 0 | 2.2 |
| 2023-10 | 0 | 1 |
| 2023-11 | 0 | 1.67 |
| 2023-12 | 0 | 1 |
| 2024-01 | 0 | 1.75 |
| 2024-02 | 0 | 1.6 |
| 2024-03 | 0 | 1.5 |
| 2024-04 | 0 | 2.11 |
| 2024-05 | 0 | 1 |
| 2024-06 | 0 | 6.5 |
| 2024-07 | 0 | 3.25 |
| 2024-08 | 0 | 7.5 |
| 2024-09 | 1 | 3.57 |
| 2024-10 | 0 | 7.8 |
| 2024-11 | 0 | 1.14 |
| 2024-12 | 0 | 2.33 |
| 2025-01 | 0 | 1.44 |
| 2025-02 | 0 | 1.67 |
| 2025-03 | 0 | 7.14 |
| 2025-04 | 0 | 1.6 |
| 2025-05 | 0 | 1.13 |
| 2025-06 | 0 | 1.57 |
| 2025-07 | 0 | 1 |
| 2025-08 | 0 | 1.71 |
| 2025-09 | 0 | 1.67 |
| 2025-10 | 0 | 1 |
| 2025-11 | 0 | 3.4 |
| 2025-12 | 0 | 2.11 |
| 2026-01 | 1 | 2.17 |
| 2026-02 | 0 | 3.6 |
| 2026-03 | 0 | 2.22 |
| 2026-04 | 2 | 3.36 |
| 2026-05 | 0 | 1.71 |
| 2026-06 | 0 | 1.17 |
Failure-mode summaryAI-generated
15 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-11 | 9681240-2026-00024 | Malfunction | Available | exact di |
| 2026-04-10 | 9681240-2026-00023 | Malfunction | Available | exact di |
| 2026-01-20 | 9681240-2025-00090 | Malfunction | Available | exact di |
| 2024-09-30 | 9681240-2024-00008 | Malfunction | Available | exact di |
| 2019-10-21 | 9681240-2019-00076 | Malfunction | Available | exact di |
| 2019-10-21 | 9681240-2019-00074 | Malfunction | Available | exact di |
| 2019-10-21 | 9681240-2019-00075 | Malfunction | Available | exact di |
| 2019-10-04 | 9681240-2019-00073 | Malfunction | Available | exact di |
| 2019-10-04 | 9681240-2019-00072 | Malfunction | Available | exact di |
| 2019-09-27 | 9681240-2019-00070 | Malfunction | Available | exact di |
| 2019-09-20 | 9681240-2019-00065 | Malfunction | Available | exact di |
| 2019-09-20 | 9681240-2019-00064 | Malfunction | Available | exact di |
| 2019-09-20 | 9681240-2019-00069 | Malfunction | Available | exact di |
| 2019-07-11 | 9681240-2019-00063 | Malfunction | Available | exact di |
| 2019-06-04 | 9681240-2019-00015 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-09-20 | NAI | No action indicated | B. BRAUN DOMINICAN REPUBLIC INC. | 0 |
| 2023-10-13 | NAI | No action indicated | B. Braun US Pharmaceutical Manufacturing, LLC | 0 |
| 2018-06-01 | NAI | No action indicated | B. Braun Medical, Inc. | 0 |
| 2018-06-01 | NAI | No action indicated | B. Braun Medical, Inc. | 0 |
| 2018-02-22 | NAI | No action indicated | B. BRAUN DOMINICAN REPUBLIC INC. | 0 |
| 2016-08-26 | VAI | Voluntary action indicated | B. Braun Medical, Inc. | 2 |
| 2016-08-26 | VAI | Voluntary action indicated | B. Braun Medical, Inc. | 2 |
| 2014-06-03 | NAI | No action indicated | B. BRAUN MEDICAL AG | 0 |
| 2013-01-10 | NAI | No action indicated | B. BRAUN DOMINICAN REPUBLIC INC. | 0 |
| 2012-12-13 | VAI | Voluntary action indicated | B. Braun Medical, Inc. | 0 |
| 2012-12-13 | VAI | Voluntary action indicated | B. Braun Medical, Inc. | 0 |
| 2012-08-16 | OAI | Official action indicated | B Braun Medical, Inc. | 6 |
| 2011-03-21 | NAI | No action indicated | B. Braun US Pharmaceutical Manufacturing, LLC | 0 |
| 2010-10-08 | OAI | Official action indicated | B Braun Medical, Inc. | 5 |
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