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.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
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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