BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG Adverse Event — Malfunction (MDR 1917413-2020-00412)
BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG Adverse Event — Malfunction (MDR 1917413-2020-00412) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG; Generic name: BLOOD SPECIMEN COLLECTION DEVICE; Manufacturer: BECTO
| Device | BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG |
|---|---|
| Generic name | BLOOD SPECIMEN COLLECTION DEVICE |
| Manufacturer | BECTON, DICKINSON & CO. (BROKEN BOW) |
| Report number | 1917413-2020-00412 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, OTHER |
| Narrative | IT WAS REPORTED THAT OVERFILL OCCURRED WITH A BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "UPON DATA ANALYSIS AND REVIEW, PRODUCT FOR TWO LOTS WAS FOUND TO HAVE DRAW VOLUMES GREATER THAN THE UPPER SPEC LIMIT OF 5.5ML. LOT 9095649: 1 FAILURE OF 30 TESTED. PRODUCT IS REQUIRED TO MEET 99% RELIABILITY WITH 95% CONFIDENCE AGAIN |
| Source | openFDA MAUDE (device adverse events) |
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