BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDPORT MRI LOW PROFILE IMPLANTED PORT WITH ATTACHABLE 6.6F

    MDR report key: 1830396 · Received August 25, 2010

    Report

    Report Number
    1830396
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 25, 2010
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTS THAT THE OUTER SHEATH IS ALMOST IMPOSSIBLE TO SPLIT AND REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDPORT MRI LOW PROFILE IMPLANTED PORT WITH ATTACHABLE 6.6F PORT, IMPLANTED, CATHETER LJT BARD ACCESS SYSTEMS, INC. * REUF0110

    Patients

    Seq Age Sex Outcome Treatment
    1 *