BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJ, OPTIV, MULI

    MDR report key: 20629460 · Received November 7, 2024

    Report

    Report Number
    1518293-2024-00019
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 7, 2024
    Report Date
    November 7, 2024
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    UDI-DI
    10746190002833
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS CASE WAS REPORTED BY A FACILITY IN FRANCE ON 09 OCTOBER 2024. CUSTOMER STATES THAT THERE WAS A CASE OF EXTRAVASATION ON THE AFTERNOON OF (B)(6) 2024. FOR A 74-YEAR-OLD PATIENT WITH FRAGILE VENOUS CAPITAL WITH THE NEW INJECTOR.THE CUSTOMER SAID HE HAD NO WARNING FROM THE INJECTOR OF A PRESSURE PROBLEM. HE HAD TO INJECT 60 ML OF CONTRAST PRODUCT + 30 ML OF NACL AT 2.2 ML WITH A BLUE CATHETER.AS CONFIRMED IN THE E-MAIL AND THE REPORT BY NATHAN BONNIN (RTR), EXTRAVASATION IS NOT LINKED TO A QUALITY DEFECT IN THE INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72593 INJ, OPTIV, MULI INJ, OPTIV, MULI IZQ LIEBEL-FLARSHEIM 844008 10746190002833

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown