BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY

    MDR report key: 2468889 · Received February 22, 2012

    Report

    Report Number
    2936999-2012-00060
    Event Type
    Death
    Date Received
    February 22, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 24, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K051416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER PHONE INVESTIGATION ON 02/22/2012 WITH COVIDIEN TECHNICAL SERVICE REPRESENTATIVE, SOMEONE PICKED UP THE TRACHS. THE CALLER CLAIMED SOMEONE FROM LIFECARE SOLUTIONS HAS THE SAMPLES. AT THIS TIME, THE SAMPLE HAS NOT BEEN RETURNED TO OUR MANUFACTURING PLANT FOR INVESTIGATION. WHEN THE SAMPLE ARRIVES, A SAMPLE ANALYSIS WILL BE PERFORMED AND INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL RESULT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE COMPANY RECEIVED A REPORT FROM A PT WIFE CLAIMING THAT SHE WAS NOT ABLE TO PASS A CATHETER DOWN THE TUBE. THE CALLER REPORTED THIS OCCURRED ON TWO DIFFERENT TUBE. THE CALLER REPORTED THAT THE FIRST FAILED TUBE WAS DISCOVERED ONE WEEK AFTER PT USE. EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED. THE CALLER REPORTED THAT THE REPLACEMENT TUBE FAILED IN THE SAME MANNER WHERE A REPLACEMENT TUBE WAS REQUIRED. DURING THE INITIAL CALL ON (B)(6) 2012 THE CALLER STATED THAT IN BOTH CASES HER HUSBAND TOLERATED THE CHANGES OF THE TRACH TUBES WELL. COVIDIEN PLACED A FOLLOW UP CALL FOR RETURN OF THE SAMPLES FOR INVESTIGATION ON (B)(6) 2012 AND THE WIFE STATED THE HUSBAND PASSED AWAY AND CLAIMS IT WAS DUE TO THE TUBE NOT FUNCTIONING CORRECTLY. SHE WAS VERY EMOTIONAL AND DID NOT PROVIDE FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY EXTENDED-LENGTH TRACHEOSTOMY TUBES JOH COVIDIEN, FORMERLY TYCO HEALTHCARE 2010028021

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R