BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENOXAPARIN 40MG/0.4ML SYRINGE

    MDR report key: 19980886 · Received August 14, 2024

    Report

    Report Number
    19980886
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 14, 2024
    Report Date
    July 15, 2024
    Manufacturer
    SANOFI-AVENTIS U.S. LLC
    Product Code
    IQG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    LOVENOX SYRINGE WOULD NOT AUTO RETRACT. WHEN ATTEMPTED TO ENGAGE SAFETY NEEDLE, NEEDLE FLEW OUT OF SYRINGE ON TO GROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234190 ENOXAPARIN 40MG/0.4ML SYRINGE ADAPTOR, HOLDER, SYRINGE IQG SANOFI-AVENTIS U.S. LLC ERLK005

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female