BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART PORT CT ANGIO CATH

    MDR report key: 18064920 · Received November 1, 2023

    Report

    Report Number
    MW5147700
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    September 6, 2023
    Report Date
    October 30, 2023
    Manufacturer
    NAVILYST MEDICAL, INC. / ANGIODYNAMICS, INC.
    Product Code
    LJT
    UDI-DI
    15051684018166
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PORT A CATH BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340205 SMART PORT CT ANGIO CATH PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT NAVILYST MEDICAL, INC. / ANGIODYNAMICS, INC. CT80STPD-VI 5669965 15051684018166

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other