BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-FLO PERFORMER

    MDR report key: 1642665 · Received March 15, 2010

    Report

    Report Number
    1642665
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    February 4, 2010
    Report Date
    March 5, 2010
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    EQUIPMENT FAILURE: BLEED BACK DEVICE POSSIBLY DETACHED FROM SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHECK-FLO PERFORMER INTRODUCER, CATHETER DYB COOK VASCULAR INC. * 2408229

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR