BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES Adverse Event — Malfunction (MDR 1917413-2020-00411)
BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES Adverse Event — Malfunction (MDR 1917413-2020-00411) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES; Generic name: BLOOD SPECIMEN COLLECTION DEVICE; Manufacturer:
| Device | BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES |
|---|---|
| Generic name | BLOOD SPECIMEN COLLECTION DEVICE |
| Manufacturer | BECTON, DICKINSON & CO. (BROKEN BOW) |
| Report number | 1917413-2020-00411 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | Other, Company representation |
| Narrative | H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. 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 RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. |
| Source | openFDA MAUDE (device adverse events) |
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