BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3954818 · Received July 17, 2014

    Report

    Report Number
    2936999-2014-00667
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF MFR IS UNK. THE USER FACILITY DID NOT REPORT A LOT NUMBER TO THE REFERENCED DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PIVOT (PVT) VALVE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION FOUND THE INFLATION LINE WAS CUT. ALL MANUFACTURING CONTROLS WERE REVIEWED AND FOUND ACCEPTABLE AND EFFECTIVE TO DETECT THE REPORTED FAILURE MODE. AN INFLATION DEFLATION TEST IS PERFORMED FOR ALL TAPERGUARD PRODUCTS. THE OPERATOR INSPECTS ALL PRODUCTS FOR NO LEAKS AND SEGREGATES THE DEFECTIVE PARTS. CUTS OF THIS MAGNITUDE AT THE TIME OF MANUFACTURING WOULD HAVE BEEN DETECTED DURING THE INFLATE DEFLATE TEST AND REMOVED FROM THE LOT. THE CUT CONDITION ON THE PVT INFLATION LINE IS NOT CONFIRMED AS RELATED TO MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE PHYSICIAN NOTICED THE TRACHEAL TUBE PILOT BALLOON HAD FALLEN DURING USE. IT WAS REPORTED THAT THE DEVICE WAS TESTED PRIOR TO USE. THOUGH REQUESTED, ADD'L PT INFO WAS NOT AVAILABLE AT THE TIME OF REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419298 SHILEY TRACHEOSTOMY TUBE BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention