BEUDAMED
    FDA Adverse Event Summary report: N

    CT SMART PORT

    MDR report key: 1883779 · Received October 11, 2010

    Report

    Report Number
    1883779
    Date Received
    October 11, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    Report Source
    User Facility report
    Reporter Location
    AR, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD PORT A CATHETER PLACED AT THIS FACILITY AND RETURNED SIX MONTHS LATER DUE TO NONFUNCTIONING CATHETER. UPON REMOVAL, IT WAS NOTED THE PORT TUBING HAD BROKEN COMPLETELY APART AND THE DETACHED PORTION HAD MIGRATED TO THE PATIENT'S HEART. THE REMAINING PORTION OF THE TUBING WAS REMOVED SUCCESSFULLY IN TACT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT SMART PORT CATHETER, IMPLANTED, PORT LJT ANGIODYNAMICS CT96STSD 995828

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR NO OTHER THERAPIES