BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE NIM EMG RE

    MDR report key: 2173409 · Received July 23, 2011

    Report

    Report Number
    1045254-2011-00051
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Report Date
    June 20, 2011
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM 3500A WAS RECEIVED FROM THE CUSTOMER. ANY MISSING OR INCOMPLETE DATA FROM THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED BY THE REPORTER DESPITE MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION, AND THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS USED FOR TREATMENT AND NOT FOR DIAGNOSIS.

    Description of Event or Problem · 1

    DESCRIPTION OF ORIGINAL COMPLAINT: AS THE EMG TUBE WAS BEING REMOVED FROM THE PACKAGING, A MEMBER OF THE ANESTHESIOLOGY TEAM NOTICED AN ELECTRODE MONITORING WIRE WAS EXTENDING FROM THE INFLATION CUFF. THE EMG TUBE WAS REMOVED AND A SECOND EXPOSED WIRE WAS SEEN EXTENDING FROM THE INFLATION CUFF. RELEVANT EVENTS AND INFORMATION OBTAINED FROM THE REPORT: THE REVIEW OF THE DEVICE HISTORY REPORT DID NOT INDICATE ANY ABNORMALITIES IN THE MANUFACTURING OF THIS LOT. A REVIEW OF THE COMPLAINT HISTORY INDICATES THERE HAVE BEEN NO REPORTS OF THIS NATURE FOR THIS LOT. ONE ITEM WAS RECEIVED AND THE REPORT WAS CONFIRMED; ONE OF THE PRODUCT ELECTRODES HAD EXITED THE LUMEN AND PIERCED THE INFLATION CUFF EXPOSING 2 CM OF THE ELECTRODE. THE CUFF WAS CAREFULLY REMOVED FROM TUBE EXPOSING THE WIRE WHICH HAD PUNCTURED IT. IT WAS THEN NOTED THAT BOTH BLUE-LEAD WIRES WERE PROTRUDING FROM THEIR RESPECTIVE LUMENS, ALTHOUGH ONLY ONE HAD PUNCTURED THE CUFF. BOTH WIRES ENTERED THEIR LUMENS PROPERLY ON THE DISTAL SIDE OF THE 30MM EXPOSURE CHANNEL, BUT HAD EXITED THE SIDE OF THE LUMENS UNDER THE CUFF. THE LUMENS WERE OBSERVED UNDER A 20X MAGNIFICATION, AND NO OTHER ANOMALIES OF THE LUMENS COULD BE DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE NIM EMG RE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229306 72737400

    Patients

    Seq Age Sex Outcome Treatment
    1