BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENOXAPARIN PREFILLED SYRINGE 40MG/0.4ML

    MDR report key: 15931820 · Received December 7, 2022

    Report

    Report Number
    15931820
    Event Type
    Malfunction
    Date Received
    December 7, 2022
    Date of Event
    November 18, 2022
    Report Date
    November 22, 2022
    Manufacturer
    FRESENIUS KABI WARRENDALE
    Product Code
    IQG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER INJECTING THE PATIENT WITH PRE-FILLED LOVENOX SYRINGE, THE BUTTON TO DEPLOY THE PROTECTANT CAP WAS PUSHED. THE SPRING OVERSHOT THE NEEDLE, CAUSING IT TO FALL OUT OF THE SYRINGE AND STICK INTO THE GROUND. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507941 ENOXAPARIN PREFILLED SYRINGE 40MG/0.4ML ADAPTOR, HOLDER, SYRINGE IQG FRESENIUS KABI WARRENDALE CN205

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown