BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2PC VSYS W/9FR INTR KIT LW PFL

    MDR report key: 2149556 · Received June 1, 2011

    Report

    Report Number
    1219930-2011-00464
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    January 13, 2011
    Report Date
    May 17, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    LJS
    PMA / PMN Number
    K961856
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE SURGEON OPENED THE INTRODUCER PACKAGE AND FOUND THE SHEATH WAS ALREADY SPLIT, AND CANNOT BE USED. ANOTHER DEVICE WAS USED TO FINISH THE PORT IMPLANTATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2PC VSYS W/9FR INTR KIT LW PFL INFUSION PORT LJS UNITED STATES SURGICAL N0A0224

    Patients

    Seq Age Sex Outcome Treatment
    1