BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART PORT CT

    MDR report key: 8517845 · Received April 16, 2019

    Report

    Report Number
    8517845
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 13, 2019
    Report Date
    March 14, 2019
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDIPORT WOULD NOT FLUSH AND DR. COULD NOT DRAW BLOOD FROM DEVICE. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313823 SMART PORT CT PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT NAVILYST MEDICAL, INC. CT66PTPD-VI

    Patients

    Seq Age Sex Outcome Treatment
    1 15330 DA