BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE

    MDR report key: 3792726 · Received May 6, 2014

    Report

    Report Number
    1045254-2014-00101
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PRODUCT EVALUATION: WHEN RECEIVED FOR ANALYSIS BY OUR QE, THE CONDITION OF THE DEVICE SHOWED CUSTOMER USE AS THERE WAS OBVIOUS PRESENCE OF BIO-RESIDUE ON THE TUBE (NEAR THE TIP). FROM VISUAL EVALUATION, ONE OUT OF THE FOUR ELECTRODE WIRES WAS FOUND OUT OF THE LUMEN, PUNCTURING THROUGH THE CUFF ASSEMBLY. THE ELECTRODE WIRE PROTRUDING FROM THE CUFF WAS FOUND BENT AND MEASURED APPROXIMATELY 8MM. THE ELECTRODE WIRE WAS ALSO FOUND SLIGHTLY BENT /LIFTED OVER THE BLUE BAND. BASED ON THE DAMAGES OBSERVED AND PREVIOUS INVESTIGATIONS PERFORMED FOR THE SAME FAILURE, IT IS LIKELY CUSTOMER MANIPULATION / HANDLING OF THE TUBE IN AN AGGRESSIVE MANNER MAY HAVE CAUSED THE ELECTRODE WIRE TO BEND, EXPOSE THROUGH THE LUMEN AND INADVERTENTLY PUNCTURE THROUGH THE CUFF ASSEMBLY. NO OTHER DAMAGES WERE NOTICED ON THE WORKING LENGTH OF THE TUBE. METHOD: MICROSCOPIC INSPECTION RESULTS: STRESS PROBLEM CONCLUSION: USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 1

    IT WAS ¿REPORTED THAT THE WIRE ON THE TUBE WAS PUSHED THROUGH AND CAUSED THE CUFF TO LEAK. THIS OCCURRED DURING THE PROCEDURE BUT THERE WAS NO PATIENT IMPACT OR INJURY. THE PATIENT DID NOT HAVE TO BE REINTUBATED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270779 ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229307 0207855091

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR