BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENOXAPARIN SODIUM INFECTION

    MDR report key: 19719507 · Received July 11, 2024

    Report

    Report Number
    19719507
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 6, 2024
    Report Date
    June 25, 2024
    Manufacturer
    FRESENIUS KABI USA, LLC
    Product Code
    IQG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN DELIVERED DOSE OF LOVENOX AS ORDERED AND THEN ACTIVATED SAFETY WHEN A SMALL PIECE BROKE OFF CAUSING THE DEVICE TO NOT KEEP THE NEEDLE IN THE SAFETY AREA. MANUFACTURER RESPONSE FOR ENOXAPARIN SODIUM INJECTION 40MG, ENOXAPARIN SODIUM INFECTION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED ON 6/25/24 TO [email protected]. EQUIPMENT IS AVAILABLE FOR RETURN TO MANUFACTURER FOR INVESTIGATION WITH MAILING LABELS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271678 ENOXAPARIN SODIUM INFECTION ADAPTOR, HOLDER, SYRINGE IQG FRESENIUS KABI USA, LLC NDC 63323-564-63 A0180026

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female