BEUDAMED
    FDA Adverse Event Summary report: N

    SHILEY TRACHEOSTOMY TUBE

    MDR report key: 1526282 · Received November 12, 2009

    Report

    Report Number
    2936999-2008-00516
    Date Received
    November 12, 2009
    Date of Event
    July 15, 2008
    Report Date
    July 21, 2008
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE SAMPLE DEVICE REPORTED HAS NOT BEEN RETURNED TO/OR RECEIVED BY THE MFR FOR FAILURE INVESTIGATION. THE LOT NUMBERS WERE PROVIDED AND THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THERE WERE NO NONCONFORMANCE REPORTS FOR THE LOTS DURING THE MANUFACTURING PROCESS. POSSIBLE CAUSES OF THIS FAILURE MODE MAY INCLUDE USER/MISHANDLING AND/OR ANATOMICAL ANOMALIES OF THE PT AIRWAY SUCH AS SHARP EDGES OF CARTILAGE. BELOW IS A LIST OF ALL MDR ACCESS NUMBERS FOR 8DCT TRACHEOSTOMY TUBES CODED WITH THE SAME FAILURE MODE: LEAK CUFF. TRACKING NO: REPORT NUMBER: 2936999-2005-000018, 060, 153, 342, 344, 2936999-2006-00040, 465, 485, 777, 899, 2936999-2007-00160, 2936999-2007-00416, 2936999-2008-00013, 017, 150, 198, 353. THE IMPROVEMENT OF THE PREVENTATIVE MAINTENANCE PROCEDURES INCLUDING INSPECTION AND REPLACEMENT OF THE MFG EQUIPMENT, COMPONENTS AND FIXTURES WAS IMPLEMENTED AS A CORRECTIVE ACTION TO PREVENT DAMAGE DURING THE CUFF MFG PROCESS.

    Description of Event or Problem · 1

    SIZE 8 SHILEY TRACH TUBES X 2, FAILED PRE-INSERTION LEAK TEST; BOTH TRACHS INFLATED WITH 15 ML AIR AND DISCOVERED TO BE LEAKING, THIRD TRACH TUBE PASSED THE LEAK TEST AND WAS INSERTED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE TUBE, TRACHESOTOMY BTO 8 DCT 0805000848

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR