BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUB Adverse Event — Malfunction (MDR 1917413-2020-00407)
BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUB Adverse Event — Malfunction (MDR 1917413-2020-00407) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUB; Generic name: BLOOD SPECIMEN COLLEC
| Device | BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUB |
|---|---|
| Generic name | BLOOD SPECIMEN COLLECTION DEVICE |
| Manufacturer | BECTON, DICKINSON & CO. (BROKEN BOW) |
| Report number | 1917413-2020-00407 |
| 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 WERE FORWARDED TO THE MANUFACTURING 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 RELEASE WE |
| Source | openFDA MAUDE (device adverse events) |
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