BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD ACCESS SYSTEMS, INC.

    MDR report key: 3066329 · Received April 15, 2013

    Report

    Report Number
    MW5029807
    Event Type
    Injury
    Date Received
    April 15, 2013
    Date of Event
    September 12, 2012
    Report Date
    April 5, 2013
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    DQO
    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) 2012. RETURNED FOR A MALFUNCTIONING CATHETER (B)(6) 2012. REPLACED CATHETER. THE TREATMENT CENTER REPORTS SLOW FLOWS WHEN HE UNDERGOES PHERESIS. CHANGES REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160722 BARD ACCESS SYSTEMS, INC. HICKMAN, TRIFUSION DQO BARD ACCESS SYSTEMS, INC. REWC1366

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention