SYRINGE INSULIN 0.5ML 31GA 8MM W10 SELF Adverse Event — Malfunction (MDR 2243072-2020-00685)
SYRINGE INSULIN 0.5ML 31GA 8MM W10 SELF Adverse Event — Malfunction (MDR 2243072-2020-00685) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SYRINGE INSULIN 0.5ML 31GA 8MM W10 SELF; Generic name: SYRINGE; Manufacturer: BECTON DICKINSON DE MEXICO.
| Device | SYRINGE INSULIN 0.5ML 31GA 8MM W10 SELF |
|---|---|
| Generic name | SYRINGE |
| Manufacturer | BECTON DICKINSON DE MEXICO |
| Report number | 2243072-2020-00685 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER, FOREIGN, OTHER |
| Narrative | H.6. INVESTIGATION: CUSTOMER RETURNED PHOTOS OF 1/2CC, 8MM, 31 SYRINGES WITH THE SHELF CARTON FROM LOT # 9168508. CUSTOMER STATES THAT THE SYRINGE SEPARATED FROM THE NEEDLE. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9168508. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PE |
| Source | openFDA MAUDE (device adverse events) |
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