BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE LUMEN CENTRAL VENOUS CATHETER SET

    MDR report key: 1020626 · Received March 28, 2008

    Report

    Report Number
    1820334-2008-00188
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    December 14, 2007
    Report Date
    March 10, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: NO PRODUCT WAS RETURNED TO ASSIST WITH OUR INVESTIGATION. THEREFORE, BASED ON THE INFO PROVIDED, WE WERE NOT ABLE TO DETERMINE WITH CERTAINTY WHY A VENOUS THROMBOSIS WAS EXPERIENCED. THE APPROPRIATE INDIVIDUALS HAVE BEEN NOTIFIED OF THIS EVENT AND WE WILL CONTINUE TO MONITOR FOR SIMILAR SITUATIONS.

    Description of Event or Problem · 1

    THE DEVICE WAS BEING UTILIZED FOR A CLINICAL STUDY. THE PT WAS A MALE ADMITTED FOR REPAIR OF A HEART DEFECT (TAPVR AND PULMONARY STENOSIS) IN 2007. THE CATHETER WAS PLACED IN THE PT'S RIGHT FEMORAL VEIN. THE FOLLOWING DAY, THE CATHETER WAS REMOVED DUE TO A RIGHT FEMORAL VEIN THROMBOSIS. THE PT WAS TREATED WITH LOVENOX. THE VENOUS THROMBOSIS REMAINED UNRESOLVED WHEN THE PT WAS DISCHARGED TWO WEEKS LATER. THE PT WAS TO CONTINUE TAKING LOVENOX AFTER DISCHARGE AND A FOLLOW-UP DOPPLER ULTRASOUND WAS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE LUMEN CENTRAL VENOUS CATHETER SET DQO CENTRAL VENOUS CATHETER DQO COOK, INC. NA 1721225

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Other