BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY XLT

    MDR report key: 3140133 · Received May 29, 2013

    Report

    Report Number
    2936999-2013-00394
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 29, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K051416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE SAMPLE OF A TRACHEOSTOMY TUBE WAS RECEIVED FOR EVALUATION. VISUAL EVALUATION FOUND NO ANOMALIES. INFLATION AND DEFLATION TESTS WERE PERFORMED BY SUBMERGING THE DEVICE IN A CONTAINER WITH WATER AND INFLATING IT WITH AIR. LEAKAGE WAS OBSERVED COMING FROM THE FLAT PILOT BALLOON. HOWEVER, DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED DURING THE MANUFACTURING INFLATION DEFLATION TESTS, AND WOULD HAVE BEEN REMOVED FROM THE LOT. THE CUSTOMER REPORTED COMPLAINT WAS VERIFIED. HOWEVER, THIS TYPE OF DEFECT IS NOT RELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE REPORTER STATES THE CUFF WOULD NOT INFLATE DURING PRETESTING OF THE TUBE. THE REPORTER CONFIRMED NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237043 SHILEY XLT EXTENDED-LENGTH TRACHEOSTOMY TUBE JOH COVIDIEN 201205752X

    Patients

    Seq Age Sex Outcome Treatment
    1