BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD ACCESS SYSTEMS, INC

    MDR report key: 3066262 · Received April 15, 2013

    Report

    Report Number
    MW5029794
    Event Type
    Injury
    Date Received
    April 15, 2013
    Date of Event
    April 26, 2011
    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) 2008. RETURNED FOR BROKEN CLAMP (B)(6) 2011. REPLACED CATHETER. (B)(6) WOMAN WITH HISTORY OF LUNG TRANSPLANTATION AND REJECTION, WHO NOW RECEIVES MONTHLY PHERESIS TREATMENTS VIA A RIGHT-SIDED TRIFUSION CATHETER. THE PT REPORTS THAT THE CLAMP ON THE BLUE LUMEN WAS BROKEN APPROXIMATELY 3 WEEKS AGO. REPLACEMENT OF THE TRIFUSION CATHETER PRIOR TO HER NEXT PHERESIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161069 BARD ACCESS SYSTEMS, INC HICKMAN, TRIFUSION LJS BARD ACCESS SYSTEM, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention