BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRAL VENOUS CATHETER

    MDR report key: 611149 · Received May 23, 2005

    Report

    Report Number
    611149
    Event Type
    Malfunction
    Date Received
    May 23, 2005
    Date of Event
    May 12, 2005
    Report Date
    May 23, 2005
    Manufacturer
    VYGONE CORP
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH PERCUTANOUS LINE WAS PERFORMED ON DUE TO NEED FOR CONTINUED IV NUTRITION AND INABILITY TO MAINTAIN PERIPHERAL IV ACCESS. THE PATIENT HAS REQUIRED BOWEL SURGERY AND HAD GRADUALLY PROGRESSED TO FEEDINGS. AT THE TIME OF THE INCIDENT, THE PERCUTANEOUS LINE WAS INFUSING LIPIDS ONLY, AND ALL OTHER IV FLUIDS HAD BEEN DISCONTINUED. THE PATIENT WAS TO GO FOR OSTOMY CLOSURE AND WOULD HAVE BEEN BACK ON TOTAL IVF THROUGH THIS PERCUTANOUS CATHETER AFTER THIS PROCEDURE.THE PATIENT HAD A WEEKLY ROUTINE XRAY DONE TO EVALUATE LUNG STATUS. IT WAS AT THIS TIME THAT THE PHYSICIAN STATED THAT THEY WERE UNABLE TO DETERMINE EXACT PLACEMENT OF THE PERCUTANOUS LINE. AN ECHOCARDIOGRAM WAS PERFORMED AND DYE WAS ALSO INJECTED INTO THE CATHETER. THE CATHETER WAS NOTED TO BE BROKEN WITH ONE PIECE IN THE HEART AND THE REMAINDER IN THE ARM. THE PATIENT HAD STABLE VITAL SIGNS AND WAS NOT IN ANY DISTRESS. THE PERCUTANEOUS CATHETER WAS REMOVED AT THE INSERTION SITE,THE PATIENT WAS THEN TRANSPORTED TO A MEDICAL HOSPITAL WHERE THE REMOVAL OF THE BROKEN PIECE LOCATED IN THE HEART WAS PERFORMED IN THE CATH. LAB. PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRAL VENOUS CATHETER CATHETER DQO VYGONE CORP * 022105FE

    Patients

    Seq Age Sex Outcome Treatment
    1 15 DA