SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP Adverse Event — Malfunction (MDR 1920898-2020-00431)
SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP Adverse Event — Malfunction (MDR 1920898-2020-00431) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP; Generic name: SYRINGE; Manufacturer: BD MEDICAL - DIABETES CARE.
| Device | SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP |
|---|---|
| Generic name | SYRINGE |
| Manufacturer | BD MEDICAL - DIABETES CARE |
| Report number | 1920898-2020-00431 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, OTHER, USER FACILITY |
| Narrative | H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF 3/10CC, 12.7MM, 29 SYRINGES WITH AN OPEN POLY BAG FROM LOT # 9203869. CUSTOMER STATES THAT A HUB WAS DETACHED WITH THE SHIELD. THE PHOTOS WERE EXAMINED AND EXHIBITED A HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL AND ONE SYRINGE WITH A DEFORMED STOPPER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9203869. ALL INSPEC |
| Source | openFDA MAUDE (device adverse events) |
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