BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD VASCULAR ACCESS CATHETER

    MDR report key: 480482 · Received August 28, 2003

    Report

    Report Number
    480482
    Event Type
    Injury
    Date Received
    August 28, 2003
    Report Date
    August 8, 2003
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BROVIAC PLACED. NECK SWELLING NOTED. BROVIAC REMOVED-CATHETER LEAK NOTED WHEN FLUSHED AFTER REMOVAL. TPN AND LIPIDS WERE INFUSING THROUGH CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD VASCULAR ACCESS CATHETER BROVIAC LJT BARD ACCESS SYSTEMS * 36H10720

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO INFUSION PUMPS (2) 3M MODEL 3000.