BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 1202812 · Received October 16, 2008

    Report

    Report Number
    1820334-2008-00561
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 18, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE SWIVEL LUER BODY HAS SEPARATED FROM THE MAIN SHAFT. HOWEVER, WE ARE UNABLE TO DETERMINE WHY THIS DIFFICULTY MAY HAVE BEEN EXPERIENCED. WE WILL CONTINUE TO MONITOR THIS DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE MIDDLE OF THE PROCEDURE, THE CATHETER WAS IN PLACE AND A TOWEL HAD BEEN PLACED OVER THE SITE WHEN IT WAS NOTED THAT THERE WAS BLOOD ON THE TOWEL. THE PT LOST 100CC OF BLOOD. THE DEVICE WAS REPLACED WITH A CHECK-FLO VALVE. THE PT DID NOT SUFFER ILL EFFECTS DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA F2254650

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other