BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNON II PLUS

    MDR report key: 1061695 · Received May 19, 2008

    Report

    Report Number
    1061695
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 8, 2008
    Report Date
    May 18, 2008
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DURING PLACEMENT OF CATHETER, PATENCY WAS CHECKED. DIFFICULTY NOTED. X-RAY REVEALED "WAISTING" OF DISTAL END OF CATHETER. CATHETER REMOVED, REPLACED WITH NEW CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNON II PLUS CATHETER, HEMODIALYSIS MSD ARROW INTERNATIONAL, INC. * RL 8026652

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR