BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2PC VSYS W/9FR INTR KIT LW PFL

    MDR report key: 1218590 · Received October 31, 2008

    Report

    Report Number
    1219930-2008-00792
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Report Date
    October 6, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 10/31/2008.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE CATHETER DOES PEEL AWAY FROM THE CONNECTOR. FURTHER DETAILS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2PC VSYS W/9FR INTR KIT LW PFL INFUSION PORT LJT NORTH HAVEN - USS

    Patients

    Seq Age Sex Outcome Treatment
    1