BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURECOMFORT INSULIN SYRINGES

    MDR report key: 1040885 · Received May 9, 2008

    Report

    Report Number
    MW5006804
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ALLISON MEDICAL, INC
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THIS PRODUCT IS AN INSULIN SYRINGE. IT COMES PACKED IN BAGS OF TEN SYRINGES AND THERE ARE TEN BAGS IN A BOX. THE PROBLEM WITH THESE SYRINGES IS THAT THE SYRINGE TIP CAPS COME OFF THE SYRINGE WHILE IN THE BAG AND WHEN PICKING UP THE INDIVIDUAL BAGS OF TEN SYRINGES, PEOPLE ARE HAVING NEEDLE STICKS BECAUSE THE TIP CAPS HAVE COME OFF AND THE BARE NEEDLE IS BREAKING THROUGH THE OUTSIDE OF THE BAGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURECOMFORT INSULIN SYRINGES INSULIN SYRINGES 1/2 INCH FMF ALLISON MEDICAL, INC 3/10CC, 30 GAUGE 71206

    Patients

    Seq Age Sex Outcome Treatment
    1 Other