BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL ARGYLE

    MDR report key: 1191866 · Received October 7, 2008

    Report

    Report Number
    1191866
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 3, 2008
    Manufacturer
    COVIDIEN KENDALL
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    INSERTED THE DUAL LUMEN UMBILICAL VESSEL CATHETER INTO THE BABY. KEPT SEEING BLOOD SEEP OUT OF LINE. DISCOVERED THE TUBING HAD A CRACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL ARGYLE CATHETER, UMBILICAL, DUAL LUMEN FOS COVIDIEN KENDALL * 635104

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA NO OTHER THERAPIES| NO OTHER THERAPIES