BD PRESET¿ Adverse Event — Malfunction (MDR 9617032-2020-00365)
BD PRESET¿ Adverse Event — Malfunction (MDR 9617032-2020-00365) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BD PRESET¿; Generic name: BLOOD SPECIMEN COLLECTION DEVICE; Manufacturer: BECTON, DICKINSON AND COMPANY (BD).
| Device | BD PRESET¿ |
|---|---|
| Generic name | BLOOD SPECIMEN COLLECTION DEVICE |
| Manufacturer | BECTON, DICKINSON AND COMPANY (BD) |
| Report number | 9617032-2020-00365 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, OTHER, USER FACILITY |
| Narrative | H.6. INVESTIGATION: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR CLOTTING WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND CLOTTING WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVI |
| Source | openFDA MAUDE (device adverse events) |
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