BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVENTIS PHARMACEUTICAL PRODUCT INC.

    MDR report key: 496658 · Received November 17, 2003

    Report

    Report Number
    496658
    Event Type
    Malfunction
    Date Received
    November 17, 2003
    Date of Event
    November 11, 2003
    Report Date
    November 15, 2003
    Manufacturer
    MFD. FOR AVENTIS PHARMACEUTICAL
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FROM A BOX OF 10 SYRINGES 3 OF THE SAFETY DEVICES ON THE SYRINGE FAILED. THE NEEDLE DID NOT RETRACT UP INTO THE SYRINGE, LEAVING THE NEEDLE EXPOSED & A GREATER POTENTIAL FOR INJURY. LOVENOX 30 MG/O.3ML SINGLE DOSE SYRINGE WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVENTIS PHARMACEUTICAL PRODUCT INC. SINGLE DOSE SYRINGE WITH AUTO. SAFETY DEVICE FMF MFD. FOR AVENTIS PHARMACEUTICAL ONE 0.3ML SYRINGE 9356

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other