BEUDAMED
    FDA Adverse Event Other Summary report: N

    JP CHANNEL DRAIN 15FR, FULL FLUTED, W/TR

    MDR report key: 1220252 · Received October 28, 2008

    Report

    Report Number
    8030107-2008-00003
    Event Type
    Other
    Date Received
    October 28, 2008
    Report Date
    October 27, 2008
    Manufacturer
    DEGANIA SILICONE, LTD.
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED THE DRAIN SAMPLE FOR INVESTIGATION - ONLY THE TUBING PART. THE DRAIN IS COMPOSED OF THE FLUTED WHITE PART THAT IS INSERTED INTO THE PATIENT AND A CLEAR TUBE. THESE TWO PARTS ARE JOINED BY A SILICONE CONNECTOR, WHICH IS GLUED TO BOTH PARTS. IN THE FAILED SAMPLE THE CLEAR CONNECTOR WAS TORN AND THE WHITE DRAIN PART WAS MISSING. WE HAVE A ROUTINE PULL TEST FOR THIS JOINT WITH A MINIMUM REQUIRED FORCE OF 40N. THE MINIMUM FOUND IN THIS LOT WAS 44.5N AND THE AVERAGE WAS 75N.

    Description of Event or Problem · 1

    "WHEN IT WAS TIME TO REMOVE THE DRAIN, THE PA PULLED HIS JVAC FROM THE PATIENT'S RIGHT UPPER QUADRANT AND IN DOING SO THE TUBING SEPARATED AT THE FUSED JUNCTION POINT; IT DID NOT BREAK AND IT WAS NOT CUT. PA ATTEMPTED TO RETRIEVE IT, WAS UNSUCCESSFUL. THE PATIENT WAS TAKEN TO THE OR THE NEXT DAY TO REMOVE IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JP CHANNEL DRAIN 15FR, FULL FLUTED, W/TR SURGERY DRAIN GCY DEGANIA SILICONE, LTD. JP 2189 P0745610

    Patients

    Seq Age Sex Outcome Treatment
    1