BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK TPN CATHETER REPAIR SET

    MDR report key: 1033011 · Received April 22, 2008

    Report

    Report Number
    1820334-2008-00229
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    December 11, 2007
    Report Date
    April 4, 2008
    Manufacturer
    COOK INCORPORATED
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: NO PRODUCT WAS RETURNED TO ASSIST WITH OUR INVESTIGATION; THEREFORE, WE WERE NOT ABLE TO DETERMINE WITH CERTAINTY WHY THE CATHETER REPAIR DID NOT HOLD. OUR QUALITY CONTROL DEPT CONFIRMS THE CORRECT SIZE AND LENGTH OF DISTAL MATERIAL, THAT THE CORRECT SIZE AND LENGTH CANNULA HAS BEEN USED, AND THAT THE DISTAL TIP OF THE CANNULA IS BLUNT WITH NO SHARP EDGES OR BURRS PRIOR TO FURTHER PROCESSING. THEY ALSO CONFIRM THE LUMEN PATENCY AND THAT THE ENTIRE CATHETER ASSEMBLY IS CLEAN AND FREE OF DAMAGES OR FLAWS. NEVERTHELESS, THE APPROPRIATE INDIVIDUALS HAVE BEEN NOTIFIED OF THIS MATTER AND WE WILL CONTINUE TO MONITOR FOR SIMILAR SITUATIONS.

    Description of Event or Problem · 1

    THE LINE WAS FIRST INSERTED SEVERAL MONTHS AGO. THE CATHETER WAS USED FOR INFUSION OF TPN AND BLOOD SAMPLING. LINE WAS REPAIRED FIVE DIFFERENT TIMES IN 2007. ON FOUR DAYS LATER, CL OPEN TO AIR. CLAMPED BLUE LIGHT WEIGHT CLAMP. CUFF HAD MIGRATED TO EXIT SITE OF CHEST WALL. IT WAS DETERMINED IT WAS NOT IN THE CHILD'S BEST INTEREST TO REPAIR THIS DEVICE A SIXTH TIME DUE TO THE HIGH RISK OF INFECTION AND THE INSUFFICIENT AMOUNT OF CL INSIDE THE PATIENT'S BODY. THE LINE WAS REMOVED VIA SURGEON IN OPERATING ROOM AND A NEW LINE WAS PLACED ON THE OPPOSITE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK TPN CATHETER REPAIR SET DQY SPECIAL SET DQY COOK INCORPORATED NA 1957219

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO