BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B-D INSULIN SYRINGES

    MDR report key: 409703 · Received August 7, 2002

    Report

    Report Number
    MW1025782
    Event Type
    Malfunction
    Date Received
    August 7, 2002
    Report Date
    August 6, 2002
    Manufacturer
    B-D
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WITHIN A BOX OF 100 SYRINGES PT FOUND TWO RIPPED PAPER PACKAGES. FROM TIME TO TIME PT HAS SEEN BLACK SPECS IN SYRINGES AND STRETCHED SEALS ON BOXES AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B-D INSULIN SYRINGES INSULIN SYRINGE KZH B-D * 0196582E

    Patients

    Seq Age Sex Outcome Treatment
    1 *