BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 1060626 · Received June 13, 2008

    Report

    Report Number
    2936999-2008-00264
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 16, 2008
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF THE TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER WAS PROVIDED AND THE MFR WILL REVIEW THE LOT HISTORY RECORDS. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE SIGNIFICANT INFO, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IN 2008, A CUSTOMER CALLED TO DISCUSS LEAKING AIR AROUND THE SEAL OF A TRACHEOSTOMY TUBE AND DID NOT REPORT ANY EVENT. LATER ON ABOUT 5 DAYS AFTER, THE CUSTOMER CALLED BACK TO REPORT A TRACHEOSTOMY TUBE WITH A LEAK WHICH HAD BEEN REPLACED A DAY PRIOR TO INITIAL CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE BTO COVIDIEN, FORMERLY TYCO HEALTHCARE DCFS 0711000647

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention