BEUDAMED
    FDA Adverse Event Death Summary report: N

    YUEH CENTESIS CATHETER NEEDLE

    MDR report key: 1401427 · Received June 10, 2009

    Report

    Report Number
    1820334-2009-00303
    Event Type
    Death
    Date Received
    June 10, 2009
    Date of Event
    May 1, 2009
    Report Date
    May 13, 2009
    Manufacturer
    COOK, INC.
    Product Code
    GCB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED TO ASSIST IN OUR INVESTIGATION. HOWEVER, WE CAN ADVISE THAT THIS CATHETER IS MADE OF TEFLON, WHICH IS BIOLOGICALLY INERT AND COMMONLY USED IN IMPLANTS. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE REPORTED DIFFICULTY, BUT HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE.

    Description of Event or Problem · 1

    THE NEEDLE AND CATHETER WERE PLACED IN THE PATIENT'S ABDOMEN TO DRAIN ASCITES FLUID. ONCE POSITIONED CORRECTLY, THE NEEDLE WAS WITHDRAWN AS THE CATHETER WAS IN THE DESIRED POSITION, WHEN THE PHYSICIAN CAME BACK LATER TO SEE THE PATIENT, HE NOTICED THE HUB OF THE CATHETER WAS ON THE FLOOR AND THAT IT HAD BROKEN AWAY FROM THE CATHETER AND THE CATHETER HAD MIGRATED INTO THE ABDOMEN OF THE PATIENT. THE PATIENT DEVELOPED AN INFECTION, WHICH MAY OR MAY NOT BE DUE TO THE CATHETER. SURGICALLY REMOVAL OF THE CATHETER IS A HIGH RISK PROCEDURE AND THE PHYSICIAN WOULD LIKE TO KNOW IF THE CATHETER MATERIAL IS INERT AND THE CONSEQUENCES OF LEAVING IT IN THE PATIENT. THE PHYSICIAN LATER BELIEVED THAT THE CATHETER WAS THE NIDUS OF THE INFECTION AND THAT IT WOULD NEED TO BE REMOVED. SOMETIME AFTER THE EVENT, THE PATIENT PASSED AWAY (ACTUAL DATE UNKNOWN); HOWEVER, THE PHYSICIAN DOES NOT BELIEVE THE INDWELLING CATHETER CONTRIBUTED TO THE DEMISE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YUEH CENTESIS CATHETER NEEDLE GCB NEEDLE, CATHETER GCB COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| O