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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.

DeviceSYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP
Generic nameSYRINGE
ManufacturerBD MEDICAL - DIABETES CARE
Report number1920898-2020-00431
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceFOREIGN, OTHER, USER FACILITY
NarrativeH.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
SourceopenFDA MAUDE (device adverse events)

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