BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK TPN DOUBLE LUMEN TPN CATHETER

    MDR report key: 3131425 · Received May 9, 2013

    Report

    Report Number
    1820334-2013-00196
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 4, 2013
    Report Date
    April 18, 2013
    Manufacturer
    COOK INC
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A NURSE WAS FLUSHING LINE. THE LINE FLUSHED WITH NO RESISTANCE THEN BROKE ABOVE THE BIFURCATION. LINE WAS STABILIZED AND COVERED. THE LINE WAS REPAIRED ON THAT DAY USING A COOK 7 FRENCH REPAIR KIT. LINE WAS ABLE TO GIVE BLOOD RETURN IN THE YELLOW LUMEN AND FLUSHED WITH NO RESISTANCE POST REPAIR. THE BLUE LUMEN WAS ALTEPLASED 24 HOURS AFTER REPAIR AND GAVE EXCELLENT BLOOD RETURN AND FLUSHED WITH NO RESISTANCE. THE LINE THEN SHOWED A TEAR ABOVE THE REPAIR SITE (APPROX. 0.5 INCHES ABOVE THE REPAIR SITE). THE PATIENT HAD A NEW LINE INSERTED IN THE OPERATING ROOM INVOLVING ANESTHETIC. ADDITIONAL INFORMATION RECEIVED (B)(4) 2013 - NURSE FLUSHING THE LINE. REPAIR NOT FULLY SUCCESSFUL, ONLY ONE LUMEN FUNCTIONED AFTER, THEREFORE PATIENT REQUIRED ANOTHER SURGERY UNDER ANESTHETIC TO GET A NEW CENTRAL LINE INSERTED. PATIENT WAS IMMUNOCOMPROMISED/NEUTROPENIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205005 COOK TPN DOUBLE LUMEN TPN CATHETER DQO, CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK INC NA 3435433

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention