BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY SCT

    MDR report key: 1036776 · Received April 30, 2008

    Report

    Report Number
    2936999-2008-00195
    Event Type
    Injury
    Date Received
    April 30, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF THE SHILEY MSCT 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

    THE CALLER STATED THAT THE CUFF DEFLATED DUE TO THE PILOT LINE POPPING OFF. THE TRACHEOSTOMY TUBE WAS REPLACED WITH A SPARE. PT WAS NOT ON A VENTILATOR. NO OTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY SCT SPECIALIZED TRACHEOSTOMY TUBE BTO COVIDIEN, FORMERLY TYCOHEALTHCARE SCT 0802001420

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention