BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPORT CT - INJECTABLE PORT

    MDR report key: 2250878 · Received September 9, 2011

    Report

    Report Number
    2250878
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 30, 2011
    Report Date
    September 9, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    THE TUBING TO THE PORT CATHETER IS FRACTURED AND NON-FUNCTIONING. PATIENT BROUGHT TO THE OPERATING ROOM FOR REMOVAL OF DEFECTIVE DEVICE AND IMPLANTATION OF NEW PORT CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTPORT CT - INJECTABLE PORT PORT, CATHETER, IMPLANTED LJT ANGIODYNAMICS CT80STPD 539992

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR