BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD ACCESS SYSTEMS

    MDR report key: 864369 · Received June 8, 2007

    Report

    Report Number
    MW5002592
    Event Type
    Injury
    Date Received
    June 8, 2007
    Date of Event
    June 4, 2007
    Report Date
    June 8, 2007
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BARD ACCESS SYSTEMS' HICKMAN CATHETER REQUIRED REPLACEMENT APPROXIMATELY 72 HOURS AFTER BEING PLACED IN PATIENT. UPON REMOVAL, THE SURGEON NOTED: "FINDINGS INCLUDED AN APPROX 5MM TEAR IN THE CATHETER ITSELF AT THE INFRACLAVICULAR SITE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ACCESS SYSTEMS HICKMAN VASCULAR ACCESS CATHETER DQO BARD ACCESS SYSTEMS NA 43JQP016

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention