BEUDAMED
    FDA Adverse Event Other Summary report: N

    T-TUBE

    MDR report key: 585313 · Received March 18, 2005

    Report

    Report Number
    585313
    Event Type
    Other
    Date Received
    March 18, 2005
    Date of Event
    February 10, 2005
    Report Date
    March 18, 2005
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A T-TUBE WAS PLACED IN THE COMMON BILE DUCT DURING AN OPEN CHOLECYSTECTOMY, AND ATTACHED TO A DRAINAGE CONTAINER. A POST-OP X-RAY SHOWED IT TO BE IN PLACE. AN X-RAY AT THE PHYSICIAN'S OFFICE ON POST-OP DAY #8 SHOWED THE T-TUBE TO BE IN 2 PIECES. THE STEM OF THE T-TUBE WAS NOT DRAINING AND WAS NOT ATTACHED TO THE HORIZONTAL "T"PIECE. THE STEM WAS PULLED OUT OF THE PATIENT. THE HORIZONTAL "T" PIECE REMAINED IN THE COMMON BILE DUCT. REMOVING THIS PIECE WILL REQUIRE AN ERCP OR FURTHER SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-TUBE 5 INCH T RADIOPAQUE GCY BARD MEDICAL DIVISION * AF41213

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR