BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOVENOX

    MDR report key: 1894480 · Received October 26, 2010

    Report

    Report Number
    1894480
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 26, 2010
    Manufacturer
    SANOFI AVENTIS
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE WAS ADMINISTERING A LOVENOX INJECTION TO THE PATIENT. WHEN SHE ACTIVATED THE SAFETY SHARPS DEVICE, THE INTERNAL SYRINGE WITH THE NEEDLE SPRUNG BACK OUT OF THE SAFETY DEVICE HITTING THE NURSE. THE INCIDENT DID NOT INVOLVE A NEEDLESTICK BUT COULD HAVE POTENTIALLY LED TO ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOVENOX SYRINGE, DRUG, PRE-FILLED FMF SANOFI AVENTIS 515948 39331

    Patients

    Seq Age Sex Outcome Treatment
    1 *