BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INSULIN SYRINGE

    MDR report key: 411868 · Received May 22, 2002

    Report

    Report Number
    MW4003326
    Event Type
    Other
    Date Received
    May 22, 2002
    Date of Event
    April 4, 2002
    Report Date
    May 22, 2002
    Manufacturer
    BD CONSUMER HEALTHCARE
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT WROTE A DETAILED REPORT REGARDING THE U100 INSULIN SYRINGES MFG BY BECTON DICKINSON & CO. COMPLAINANT PURCHASED 100 SYRINGES AND STATES THAT THEY CUT THEIR FINGER ON A SHARP PLASTIC MOLDING MARK AT THE (1) UNIT. SAYS THAT THEY ARE MUCH STIFFER AND FOUND FINEWIRE/PLASTIC HAIR AND DEBRIS ON THE WHITE PISTON ROD AND WAS UNABLE TO USE THE SYRINGE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM PT 9/22/03: VERY ODD DIABETIC SYRINGE, MODIFICATION TO NEEDLE BODY. THREE CRIMPS ON EACH SIDE, 180 DEGREES OPPOSITE AND SPACED. SOME HAVE 4 CRIMPED PLACES. SOME 6-7 PLACES. THEY ALSO HAD SOME WHITISH/GREY MATERIAL ON THE NEEDLE AND IT WAS TRI-SODIUM NITRATE-VERY PAINFUL TO TOUCH THE SUBCUTANEOUS SKIN WITH THIS POINT. THE WHOLE 1/2" LENGTH DIRTY, BENT AND HAS A YELLOWISH LAQUER ON IT. THE PUSH NECESSARY TO INSERT WAS 5-8 TIMES MORE PRESSURE. THE SKIN STUCK TO THE NEEDLE AND PIMPLED UP WHEN RECOVERING THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSULIN SYRINGE INSULIN SYRINGE FMF BD CONSUMER HEALTHCARE NA 1072029 RUN H33

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other