BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH

    MDR report key: 16291 · Received February 4, 1994

    Report

    Report Number
    16291
    Event Type
    Injury
    Date Received
    February 4, 1994
    Date of Event
    August 3, 1993
    Report Date
    August 30, 1993
    Manufacturer
    PHARMACIA DELTEC, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 8/5/93, AN ARTERIOGRAM WAS PERFORMED TO REMOVE A FRAGMENT WHICH HAD COME FROM THE PORTACATH. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED FROM THE LEFT PULMONARY ARTERY.ON 8/16/93, THE REMAINDER OF THE PORTACATH WAS REMOVED DURING AN OUTPATIENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT-A-CATH Implant VENOUS ACCESS CATHETER LJT PHARMACIA DELTEC, INC. 18846A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening