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.
261 linked reportsMalfunction 244Injury 17
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-06 | 0 | 1 |
| 2020-04 | 0 | 1 |
| 2021-01 | 2 | 2 |
| 2021-02 | 1 | 1 |
| 2021-03 | 1 | 1 |
| 2021-04 | 2 | 2 |
| 2021-06 | 3 | 3 |
| 2021-07 | 3 | 3 |
| 2021-08 | 2 | 2 |
| 2021-09 | 1 | 1 |
| 2021-11 | 5 | 5 |
| 2021-12 | 1 | 1 |
| 2022-01 | 11 | 11 |
| 2022-03 | 8 | 8 |
| 2022-06 | 3 | 3 |
| 2022-08 | 1 | 1 |
| 2022-10 | 1 | 1 |
| 2022-12 | 5 | 5 |
| 2023-02 | 13 | 13 |
| 2023-03 | 2 | 2 |
| 2023-04 | 4 | 4 |
| 2023-05 | 3 | 2.5 |
| 2023-06 | 7 | 7 |
| 2023-08 | 2 | 2 |
| 2023-09 | 1 | 1 |
| 2023-10 | 1 | 1 |
| 2023-11 | 2 | 2 |
| 2023-12 | 4 | 4 |
| 2024-01 | 1 | 1 |
| 2024-02 | 9 | 9 |
| 2024-03 | 4 | 4 |
| 2024-04 | 3 | 3 |
| 2024-05 | 3 | 3 |
| 2024-06 | 4 | 4 |
| 2024-07 | 1 | 1 |
| 2024-10 | 3 | 3 |
| 2024-11 | 6 | 6 |
| 2025-03 | 5 | 5 |
| 2025-05 | 6 | 6 |
| 2025-06 | 1 | 1 |
| 2025-07 | 7 | 4 |
| 2025-08 | 3 | 3 |
| 2025-09 | 28 | 28 |
| 2025-10 | 1 | 2.5 |
| 2025-11 | 10 | 10 |
| 2025-12 | 4 | 4 |
| 2026-01 | 7 | 7 |
| 2026-02 | 56 | 56 |
| 2026-03 | 1 | 1 |
| 2026-05 | 4 | 5 |
| 2026-06 | 5 | 4 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-08 | 3006948883-2026-00383 | Malfunction | Available | exact di |
| 2026-06-03 | 3006948883-2026-00376 | Malfunction | Available | exact di |
| 2026-06-03 | 3006948883-2026-00373 | Malfunction | Available | exact di |
| 2026-06-03 | 3006948883-2026-00375 | Malfunction | Available | exact di |
| 2026-06-03 | 3006948883-2026-00374 | Malfunction | Available | exact di |
| 2026-05-21 | 3006948883-2026-00350 | Malfunction | Available | exact di |
| 2026-05-21 | 3006948883-2026-00347 | Malfunction | Available | exact di |
| 2026-05-21 | 3006948883-2026-00348 | Malfunction | Available | exact di |
| 2026-05-21 | 3006948883-2026-00349 | Malfunction | Available | exact di |
| 2026-03-03 | 3006948883-2026-00181 | Malfunction | Available | exact di |
| 2026-02-20 | 3006948883-2026-00157 | Malfunction | Available | exact di |
| 2026-02-20 | 3006948883-2026-00156 | Malfunction | Available | exact di |
| 2026-02-20 | 3006948883-2026-00155 | Malfunction | Available | exact di |
| 2026-02-10 | 3006948883-2026-00116 | Malfunction | Available | exact di |
| 2026-02-10 | 3006948883-2026-00122 | Malfunction | Available | exact di |
Showing the most recent 200 of 261 linked reports.
Showing 1–15 of 200
Regulatory clearances
- 510(k)K122718Substantially equivalent (SESE) · 2013-02-06clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-04-16 | NAI | No action indicated | Becton Dickinson and Co. | 0 |
| 2026-04-16 | NAI | No action indicated | Becton Dickinson and Co. | 0 |
| 2025-08-01 | NAI | No action indicated | Becton Dickinson & Co. | 0 |
| 2024-05-21 | NAI | No action indicated | Becton Dickinson Infusion Therapy Systems, Inc. | 0 |
| 2024-05-02 | VAI | Voluntary action indicated | BECTON, DICKINSON AND CO. | 3 |
| 2024-05-02 | VAI | Voluntary action indicated | BECTON, DICKINSON AND CO. | 3 |
| 2024-02-29 | NAI | No action indicated | Becton Dickinson Industrias Cirurgicas, LTDA. | 0 |
| 2023-09-15 | NAI | No action indicated | Becton Dickinson and Company | 0 |
| 2023-09-15 | NAI | No action indicated | Becton, DIckinson and Company | 0 |
| 2023-09-15 | NAI | No action indicated | Becton, DIckinson and Company | 0 |
| 2023-09-15 | NAI | No action indicated | Becton Dickinson and Company | 0 |
| 2023-08-02 | VAI | Voluntary action indicated | BD Medical | 0 |
| 2023-03-23 | NAI | No action indicated | Becton, Dickinson and Company | 0 |
| 2023-03-23 | NAI | No action indicated | Becton, Dickinson and Company | 0 |
| 2023-01-11 | NAI | No action indicated | Becton Dickinson and Co. | 0 |
| 2023-01-11 | NAI | No action indicated | Becton Dickinson and Co. | 0 |
| 2022-12-15 | NAI | No action indicated | Becton Dickinson Industrias Cirurgicas, LTDA. | 0 |
| 2021-11-23 | VAI | Voluntary action indicated | BD Puerto Rico LLC | 0 |
| 2021-07-29 | NAI | No action indicated | Becton Dickinson Caribe LTD | 0 |
| 2021-07-23 | VAI | Voluntary action indicated | Becton Dickinson & Co. | 1 |
| 2018-01-11 | WL | Warning Letter | Becton Dickinson & Company | — |
| 2009-05-11 | WL | Warning Letter | Becton Dickinson & Company | — |
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