BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE COMFORT INSULIN SYRINGE

    MDR report key: 3685300 · Received March 12, 2014

    Report

    Report Number
    MW5034961
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 11, 2014
    Manufacturer
    ALLISON MEDICAL INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USING SURE COMFORT INSULIN SYRINGES FOR INJECTION OF INSULIN. HAVING TROUBLE FOR SEVERAL WEEKS IN GIVING SHOTS. THE NEEDLE HURT WHEN IT WAS PUT INTO SITE FOR INJECTION. AFTER THE NEEDLE WAS IN THE SKIN, WAS UNABLE TO INJECT THE INSULIN, COULDN'T PUSH THE INSULIN IN. HAD TO WITHDRAW THE NEEDLE AND TRY DIFFERENT SYRINGES. SOMETIMES, USED UP TO 7 SYRINGES TO FIND ONE THAT THE INSULIN COULD BE PUSHED THROUGH. THIS DELAYED IN GETTING THE INSULIN GIVEN BY UP TO 2 HOURS PAST THE CORRECT TIME. IN INSPECTING THE NEEDLES WITH A MAGNIFYING GLASS, NOTED THAT THE BEVEL OF THE NEEDLE WAS BENT OVER. IN FURTHER TESTING OF THE NEEDLE, DISCOVERED THAT THE BENDING OF THE NEEDLE HAPPENED WHEN THE NEEDLE WAS STUCK INTO THE VIAL OF INSULIN. THIS IS A SERIOUS SAFETY CONCERN FOR NOT GETTING THE CORRECT AMOUNT OF INSULIN AND FOR THE POSSIBILITY THAT THE BENDED PART OF THE NEEDLE WOULD BREAK OFF INSIDE MY BODY. IT ALSO CAUSED MORE PAIN WITH THE INSERTION OF THE BENT PART OF THE NEEDLE INTO MY BODY. I HAVE CHANGED TO ANOTHER SOURCE FOR MY SYRINGES/NEEDLES AND HAVE HAD NO FURTHER PROBLEM WITH INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149234 SURE COMFORT INSULIN SYRINGE SURE COMFORT INSULIN SYRINGE FMI ALLISON MEDICAL INC. NDC: 86227-0701-05 30427

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR