BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESIO PORTA-CATHETER

    MDR report key: 147636 · Received January 27, 1998

    Report

    Report Number
    MW1012935
    Event Type
    Malfunction
    Date Received
    January 27, 1998
    Date of Event
    December 31, 1997
    Report Date
    January 20, 1998
    Manufacturer
    SPECIALTY MEDICAL SYSTEMS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PORTA CATHETER PLACED ON 12/31/97 WITHOUT DIFFICULTY. SOMETIME LATER, THE CATHETER WAS NOT WORKING WELL. AN X-RAY WITH CONTRAST DYE SHOWED THE LINE WAS LEAKING THROUGH A HOLE. THE LINE HAD APPARENTLY BROKEN OFF. IT IS BELIEVED THAT MOVEMENT OF PT'S CLAVICLE SHEARED THE LINE. UPDATE: BROKEN CATHETER HAS BEEN SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESIO PORTA-CATHETER Implant CATHETER LJT SPECIALTY MEDICAL SYSTEMS, INC. * 36HH2604

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR