BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE COMFORT INSULIN SYRINGES 3/10CC 5/16" LENGTH 31 GAUGE NEEDLE

    MDR report key: 8014248 · Received October 26, 2018

    Report

    Report Number
    MW5080870
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    October 24, 2018
    Report Date
    October 25, 2018
    Manufacturer
    ALLISON MEDICAL INC.
    Product Code
    FMI
    UDI-DI
    00786227650357
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM AN INSULIN DEPENDENT DIABETIC. I GOT A NEW BOX OF SYRINGES FROM MY PHARMACY, AS I HAD USED UP THE LAST BOX. I AM HAVING A VERY HARD TIME REMOVING THE CAPS ON THIS LOT OF SYRINGES. MY DAUGHTER (WHO IS AN EMT) IS ALSO HAVING GREAT DIFFICULTY REMOVING THE CAPS. SO MUCH FORCE IS NEEDED, I HAVE STUCK MY FINGER A FEW TIMES TRYING TO REMOVE THE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851341 SURE COMFORT INSULIN SYRINGES 3/10CC 5/16" LENGTH 31 GAUGE NEEDLE NEEDLE, HYPODERMIC, SYRINGE LUMEN FMI ALLISON MEDICAL INC. 22-6503 180320AS 00786227650357

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other