BEUDAMED
    FDA Adverse Event Summary report: N

    CHEMOSITE VENOUS ACCESS SYSTEM

    MDR report key: 30563 · Received January 8, 1995

    Report

    Report Number
    30563
    Date Received
    January 8, 1995
    Manufacturer
    DEVICE LABS, INC.
    Product Code
    LJT
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MALFUNCTIONING PORT. CHEST FLUOROSCOPY PERFORMED. FINDINGS SHOWED LEAKAGE FROM THE MORE PROXIMAL PORTION OF THE CATHETER AT THE AREA OF THE JUNCTION OF THE RIGHT SUBCLAVIAN VEIN. SUGGESTS PARTIAL TEAR OF THE CATHETER. ON 8/16/95 SURGICAL REMOVAL OF CATHETER. DURING REMOVAL CATHETER BROKE OFF. PORTABLE CHEST X-RAY DEMONSTRATES 13 CM LONG SEGMENT OF CATHETER IN THE SUPERIOR VENA CAVA AND RIGHT ATRIUM. AN INFERIOR VENOCAVOGRAM PERFORMED VIA RIGHT SUPERFICIAL FEMORAL VEIN. SUCCESSFUL REMOVAL OF 13CM LONG FRAGMENT OF CATHETER. PT TOLERATED PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMOSITE VENOUS ACCESS SYSTEM Implant CHEMOSITE CATHETER LJT DEVICE LABS, INC. UNKNOWN 9405

    Patients

    Seq Age Sex Outcome Treatment
    1 *