BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EUROMI

    MDR report key: 16635664 · Received March 29, 2023

    Report

    Report Number
    3007697975-2023-00001
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    March 14, 2023
    Report Date
    March 29, 2023
    Manufacturer
    EUROMI
    Product Code
    GEA
    UDI-DI
    03701416202718
    PMA / PMN Number
    878.4800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE CAN OBSERVE THAT THE CANNULA WAS TIGHTENED WITH A TOOL. THE ASSOCIATED SCRATCHES ARE NOT A NORMAL PHENOMENON WHEN TIGHTENING THE CANNULA, SO WE ASSUME THAT THE SURGEON IS NOT USING THE CORRECT CLAMPING KEY. IN ADDITION, THE LUER CONNECTOR HAS LOOSENED, IT IS ALSO ASSUMED THAT IT WAS TIGHTENED WITH A CLAMP, HOWEVER THE PROCEDURE INDICATES THAT THIS FEMALE CONNECTOR MUST BE HAND-TIGHTENED. THIS IS THE USE OF AN UNSUITABLE TOOL FOR TIGHTENING THE CANNULA AND CONNECTOR BY THE SURGEON.

    Description of Event or Problem · 0

    2 CANNULAS WITH UNWELDED LUER CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650859 EUROMI CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY GEA EUROMI EVAMATIC INFILTRATION 22AHAI006L4 03701416202718

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other