BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH II

    MDR report key: 507357 · Received January 12, 2004

    Report

    Report Number
    MW1030798
    Event Type
    Injury
    Date Received
    January 12, 2004
    Date of Event
    November 25, 2003
    Report Date
    January 9, 2004
    Manufacturer
    SMITHS-MEDICAL MD INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PORT-A-CATH DEVICE NON FUNCTIONING. PT TAKEN TO SURGERY FOR REMOVAL OF THE IMPLANTED DEVICE. UPON REMOVAL THE CATHETER APPEARED SHORTENED. AN X-RAY REVEALED A CATHETER FRAGMENT IN THE PULMONARY ARTERY OUTFLOW TRACT. THE PT HAD AN EPISODE OF CHEST PAIN AFTER THE PROCEDURE TO REMOVE BY VIA INTERVENTIONAL RADIOLOGY PROCEDURE -ANGIOGRAM-. RISK MANAGEMENT NOT AWARE OF EVENT UNTIL 12/2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT-A-CATH II IMPLANTED VENOUS ACCESS DEVICE LJT SMITHS-MEDICAL MD INC. NI M25514

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention