BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD ACCESS SYSTEMS, INC

    MDR report key: 3066319 · Received April 15, 2013

    Report

    Report Number
    MW5029811
    Event Type
    Injury
    Date Received
    April 15, 2013
    Date of Event
    June 22, 2009
    Report Date
    April 5, 2013
    Manufacturer
    BARD ACCESS SYSTEM, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TRIFUSION PLACEMENT (B)(6) 2009. RETURNED FOR A BROKEN CLAMP (B)(6) 2009. REPLACED CATHETER. A (B)(6) MALE WITH A BILATERAL LUNG TRANSPLANT AND KIDNEY TRANSPLANT, REQUIRING TRIFUSION CATHETER FOR PHOTO PHERESIS. PATIENT HAD A RIGHT INTERNAL JUGULAR TRIFUSION CATHETER PLACED IN (B)(6) 2008 AND EXCHANGED IN (B)(6) 2009. HE IS SEEN HERE TODAY FOR AN EXCHANGE OF HIS TRIFUSION CATHETER SECONDARY TO A BROKEN CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160721 BARD ACCESS SYSTEMS, INC HICKMAN, TRIFUSION LJS BARD ACCESS SYSTEM, INC. RESK0223

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention