BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTI-FLOW PC D/L 23CM KI

    MDR report key: 487226 · Received October 2, 2003

    Report

    Report Number
    1720496-2003-00185
    Event Type
    Death
    Date Received
    October 2, 2003
    Date of Event
    October 2, 2003
    Report Date
    October 2, 2003
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BY ADVANCING THE DILATOR/INTRODUCER OVER THE GUIDEWIRE, THE SURGEON PERFORATED THE INTERNAL JUGULAR LEFT VEIN, ENTERING THE MEDIASTINUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FLOW PC D/L 23CM KI IMPLANTED BLOOD ACCESS DEVICE MSD BARD ACCESS SYSTEMS 5644230 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death