BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK TPN DOUBLE LUMEN TPN CATHETER

    MDR report key: 3131424 · Received May 9, 2013

    Report

    Report Number
    1820334-2013-00222
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 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

    AN ANESTHESIOLOGIST IN NUCLEAR MEDICINE 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 PROCEDURE REQUIRED TWO REPAIR KITS. THE FIRST REPAIR KIT WAS DEFECTIVE, THE PLASTIC SHEATH WAS NOT ABLE TO GO OVER THE METAL REPAIR SHEATHS AND REQUIRED A LOT OF MANIPULATION SO IT WAS DEEMED UNRELIABLE AND UNSAFE. ADDITIONAL INFORMATION PROVIDED (B)(4) 2013: PATIENT WAS NEUTROPENIC AND SEDATED DURING THE PROCEDURE WHICH REQUIRED HIM TO GET MORE SEDATION THAN WAS ORIGINALLY PLANNED AS THE PROCEDURE TOOK A LONG TIME DUE TO THE REPAIR KIT NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204871 COOK TPN DOUBLE LUMEN TPN CATHETER DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK INC NA 2758079

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention