BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOVENOX 40 MG

    MDR report key: 2821138 · Received October 24, 2012

    Report

    Report Number
    MW5027461
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 23, 2012
    Manufacturer
    SANOFI-AVENTIS US LLC
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER ADMINISTRATING A LOVENOX ING AND PRESSED DOWN ON THE YELLOW SYRINGE PLUNGER TO SHEATH THE NEEDLE, INSTEAD OF COVERING THE NEEDLE IT SHOT THE UNCOVERED NEEDLE OUT THE END AND INTO THE PTS BED. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOVENOX 40 MG SINGLE DOSE SYRINGE WITH AUTO SAFETY DEVICE FMF SANOFI-AVENTIS US LLC 2LD62A

    Patients

    Seq Age Sex Outcome Treatment
    1