BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORT CATHETER

    MDR report key: 1317510 · Received February 19, 2009

    Report

    Report Number
    MW5009987
    Event Type
    Malfunction
    Date Received
    February 19, 2009
    Date of Event
    February 6, 2009
    Report Date
    February 10, 2009
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A BARD PORT-A-CATH HAD BEEN PLACED IN LATE 2007 FOR CENTRAL VENUS ACCESS. AS THE PORT-A-CATH WAS NO LONGER NEEDED, SURGICAL PROCEDURE TO REMOVE THE PORT-A-CATH FROM THE RIGHT CHEST WALL WAS PERFORMED. THE PORT-A-CATH POCKET WAS ENTERED AND THE THREE STITCHES HOLDING THE PORT-A-CATH WERE CUT. EXAMINATION OF THE PRT-A-CATH REVEALED THAT ONLY THREE OF THE FOUR PARTS OF THE PORT-A-CATH HAD BEEN REMOVED AND HE SILASTIC TUBING THAT LAY OVER THE CATHETER WAS STILL MISSING. FURTHER EXAMINATION OF THE SURGICAL FIELD REVEALED THAT THE SILASTIC TUBING WAS LOCATED APPROXIMATELY 1 CM AWAY FROM THE POCKET WHERE THE PORT-A-CATH HAD BEEN. THIS WAS RESECTED AND THE TUBING WAS REMOVED FROM THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT CATHETER PORT-A-CATH LJT BARD ACCESS SYSTEMS, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other