BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORT-A-CATH

    MDR report key: 33858 · Received May 3, 1996

    Report

    Report Number
    33858
    Event Type
    Malfunction
    Date Received
    May 3, 1996
    Date of Event
    April 22, 1996
    Report Date
    May 1, 1996
    Manufacturer
    PHARMACIA DELTEC, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD PORT INSERTED 10/95 AT ANOTHER AREA HOSP. WAS ADMITTED TO THIS FACILITY FOR SURGICAL REMOVAL OF THE PORT BECAUSE IT HAD CRACKED DUE TO MUSCLE AND BONE RUBBING TOGETHER. FRACTURE OF CATHETER CONFIRMED BY VENOGRAM. UPON REMOVAL OF CATHETER, CATHETER WAS FOUND TO BE ADHERED TO LEFT SUBCLAVIAN VEIN AND VENA CAVA. TIP OF CATHETER COULD NOT BE FREED UP, AND REMAINS ADHERED. THUS, PT HAS RETAINED FOREIGN BODY (TIP OF CATHETER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT-A-CATH Implant VASCULAR ACCESS DEVICE LJT PHARMACIA DELTEC, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR