BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 6988174 · Received October 30, 2017

    Report

    Report Number
    8020889-2017-05166
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    January 12, 2017
    Report Date
    October 30, 2017
    Manufacturer
    TUBE, BRONCHIAL (W/WO CONNECTOR)
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY FILED UNDER REPORT #2936999-2017-00093. THE SAMPLE WAS RETURNED AND VISUAL EXAMINATION SHOWED THAT THE SHAPE RETURNED UNIT HAD BEEN ALTERED USING THE STYLET WIRE. THE STYLET WIRE WAS REMOVED AND INFLATION/DEFLATION TESTING WAS SUCCESSFUL. THERE WAS NO FAULT FOUND WITH THE DEVICE. THE PROBABLE ROOT CAUSE IS THAT THE CUFF TEST WAS CARRIED OUT WHEN THE SHAPE OF THE TUBE WAS INCORRECTLY ALTERED WITH THE STYLET WIRE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IT WAS NECESSARY TO ADD A MORE PRONOUNCED CURVATURE ON THE ENDOBRONCHIAL TUBE, AS REQUIRED DURING A DIFFICULT INTUBATION WITH THE GLIDESCOPE. THE TRACHEAL AND BRONCHIAL CUFF INFLATED AND DEFLATED PRIOR TO INSERTION TO THE TEST THE CUFF. AS THIS WAS A DIFFICULT INTUBATION, THE TUBE TIP WAS CURVED TO TEST THE CUFF. THE TRACHEAL CUFF COULD BE INFLATED BUT NOT BE DEFLATED COMPLETELY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768221 SHILEY TUBE, BRONCHIAL (W/WO CONNECTOR) BTS TUBE, BRONCHIAL (W/WO CONNECTOR) 125041

    Patients

    Seq Age Sex Outcome Treatment
    1