BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART PORT CT

    MDR report key: 12384046 · Received August 30, 2021

    Report

    Report Number
    12384046
    Event Type
    Malfunction
    Date Received
    August 30, 2021
    Date of Event
    July 22, 2021
    Report Date
    August 2, 2021
    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

    IMPLANT DEFECTIVE. THE SLEEVE WOULD NOT ATTACH TO PORT. REF: CT66PTPDVI1. LOT: 5674817. EXP: 02/29/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282638 SMART PORT CT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT NAVILYST MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA