BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE Adverse Event — Malfunction (MDR 9617032-2020-00373)
BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE Adverse Event — Malfunction (MDR 9617032-2020-00373) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE; Generic name: BLOOD SPECIMEN COLLECTION DEVICE; Manufacturer: BECTON, DICKINSON AND COM
| Device | BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE |
|---|---|
| Generic name | BLOOD SPECIMEN COLLECTION DEVICE |
| Manufacturer | BECTON, DICKINSON AND COMPANY (BD) |
| Report number | 9617032-2020-00373 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, OTHER, USER FACILITY |
| Narrative | INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELE |
| Source | openFDA MAUDE (device adverse events) |
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