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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.

DeviceSYRINGE INSULIN 0.5ML 31GA 8MM W10 SELF
Generic nameSYRINGE
ManufacturerBECTON DICKINSON DE MEXICO
Report number2243072-2020-00685
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCONSUMER, FOREIGN, OTHER
NarrativeH.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
SourceopenFDA MAUDE (device adverse events)

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