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RELION INSULIN SYRINGE Adverse Event — Malfunction (MDR 1920898-2020-00435)

RELION INSULIN SYRINGE Adverse Event — Malfunction (MDR 1920898-2020-00435) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: RELION INSULIN SYRINGE; Generic name: PISTON SYRINGE; Manufacturer: BD MEDICAL - DIABETES CARE.

DeviceRELION INSULIN SYRINGE
Generic namePISTON SYRINGE
ManufacturerBD MEDICAL - DIABETES CARE
Report number1920898-2020-00435
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCONSUMER, OTHER
NarrativeDATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR PLUNGER ROD DIFFICULT TO MOVE DUE TO UNKNOWN LOT NUMBER. NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.
SourceopenFDA MAUDE (device adverse events)

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