BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPORT

    MDR report key: 2073096 · Received April 21, 2011

    Report

    Report Number
    2073096
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    November 4, 2010
    Report Date
    April 21, 2011
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT. CAME IN FOR PORT CATHETER REMOVAL. MD REMOVED RIGHT INTERNAL JUGULAR "POWERPORT." PT. LATER IDENTIFIED LUMP UNDER SKIN; ULTRASOUND REVEALED A SMALL PIECE OF PLASTIC FROM THE "POWERPORT" PORT" RETAINED AFTER PORT CATHETER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERPORT PORT, IMPLANTED, CATHETER LJT BARD ACCESS SYSTEMS, INC. 1808060 RESE0776

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR