BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH PAS PORT IMPLANTABLE ACCESS SYSTEM

    MDR report key: 35535 · Received July 1, 1996

    Report

    Report Number
    35535
    Event Type
    Injury
    Date Received
    July 1, 1996
    Date of Event
    February 7, 1996
    Report Date
    February 15, 1996
    Manufacturer
    PHARMACIA DELTEC, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED CATHETER ON 2/5/96. ON 2/7/96 RETURNED TO CLINIC AND NO BLOOD COULD BE RETURNED FROM THE CATHETER. UNDER FLUOROSCOPY THE CATHETER WAS NOTED TO BE DETACHED FROM THE PORT AND COILED IN THE RIGHT VENTRICLE. PORT WAS IMMEDIATELY REMOVED FROM LEFT INNER ARM, AND SENT TO HOSP FOR REMOVAL OF CATHETER FROM HER HEART. THE LOCKING MECHANISM ON THE PORT FAILED TO SECURE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT-A-CATH PAS PORT IMPLANTABLE ACCESS SYSTEM Implant VENOUS CATHETER SYSTEM LJT PHARMACIA DELTEC, INC. * 23200

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention