BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO NEEDLE PRO FIXED NEEDLE INSULIN SYRINGE 1ML

    MDR report key: 2994439 · Received February 28, 2013

    Report

    Report Number
    MW5029262
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE HAS VISIBLE CONTAMINANTS ON THE NEEDLE. MULTIPLE UNITS FROM SAME LOT NUMBER EXAMINED AND ALL APPEAR CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86694 JELCO NEEDLE PRO FIXED NEEDLE INSULIN SYRINGE 1ML INSULIN SYRINGE FMF SMITHS MEDICAL ASD, INC. 2356156

    Patients

    Seq Age Sex Outcome Treatment
    1