BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE COMFORT INS SYR 0.5ML10/31G5/16

    MDR report key: 18040488 · Received October 30, 2023

    Report

    Report Number
    MW5147522
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Date of Event
    October 15, 2023
    Report Date
    October 24, 2023
    Manufacturer
    ALLISON MEDICAL, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT SAID THERE IS AN ISSUE WITH THE PLUNGER, IT ISN'T SUCKING ANY INSULIN OF THE VIAL - HE IS INJECTING AIR INTO THE VIAL "FIRST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2100846 SURE COMFORT INS SYR 0.5ML10/31G5/16 SYRINGE, PISTON FMF ALLISON MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male