BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN 13.5 FR HEMODIALYSIS CATHETER

    MDR report key: 219797 · Received April 15, 1999

    Report

    Report Number
    1720496-1999-00087
    Event Type
    Malfunction
    Date Received
    April 15, 1999
    Date of Event
    October 15, 1998
    Report Date
    October 19, 1998
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLACED 6/19/98. PT RETURNED TO FACILITY ON 10/16/98 WITH CATHETER BROKEN IN HALF. THE CATHETER WAS CLAMPED. REMOVED & REPLACED "OTG" WITHOUT DIFFICULTY. NO EMBOLISM. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HICKMAN 13.5 FR HEMODIALYSIS CATHETER Implant BLOOD ACCESS DEVICE DQO BARD ACCESS SYSTEMS 0600662 36DI7286

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention