BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA

    MDR report key: 19749027 · Received July 16, 2024

    Report

    Report Number
    19749027
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    February 26, 2024
    Report Date
    April 24, 2024
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHEN THE PACKAGE WAS OPENED TO STERILE FIELD, THE SCRUB TECH AND SURGEON FOUND THE PORT UNABLE TO BEND AND HAD TO OPEN ANOTHER PORT. THEY DID NOT KEEP THE DEFECTIVE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2503781 XCELA PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT NAVILYST MEDICAL, INC. 44035 5767162

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown