BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PED

    MDR report key: 1051079 · Received May 21, 2008

    Report

    Report Number
    2936999-2008-00227
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 29, 2008
    Manufacturer
    COVIDIEN/ FORMERLY TYCO HEADQUARTERS
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    WHEN THE TRACHEOSTOMY TUBE WAS INSERTED, THE PT SAID IT FELT HARD. WE COULD SEE IT LOOKED HIGHER AND WAS DIGGING INTO HIS NECK. ON CHANGING, THE PT'S NECK WAS RED AND MARKED. WHEN THE PARENTS COMPARED THE REMOVED TUBE TO AN UNUSED TUBE, THEY NOTED THAT THE ANGLE OF THE CANNULA BEND WAS LESS IN THE USED DEVICE THAN IN THE UNUSED ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PED TRACHEOSTOMY TUBE BTO COVIDIEN/ FORMERLY TYCO HEADQUARTERS 4.5PED 0706001645

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention