BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY 4DCT

    MDR report key: 1051077 · Received May 21, 2008

    Report

    Report Number
    2936999-2008-00213
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO SAMPLE TO RETURN FOR FAILURE INVESTIGATION. THE LOT NUMBER IS UNK. THERE IS NO ALLEGED DEFECT OF THE SIZE 4 INNER CANNULA OR THE SIZE 6 OUTER CANNULA.

    Description of Event or Problem · 1

    THE CALLER REPORTED A NURSE GRABBED THE WRONG INNER CANNULA AND PUT A SIZE 4 INNER CANNULA IN A SIZE 6 TRACHEOSTOMY TUBE. THE PT WAS VENTILATED AND THE OXIMETER WAS ALARMING AND THE PT WAS DESATURATING. THEY TRIED GIVING ADDITIONAL OXYGEN AND INFLATING THE CUFF MORE AND ADJUSTING THE PEEP. THIS HAPPENED FOR ABOUT 8 HOURS AND WHEN THE CALLER CAME IN SHE NOTICED THE LEAK AND IT WAS KIND OF A HISSING NOISE. THE CALLER REPORTED SHE THEN SAW THE PACKAGE FOR THE INNER CANNULA AND SAW IT WAS A SIZE 4 AND REMOVED THE INNER CANNULA AND VERIFIED IT WAS A SIZE 4. THE CALLER REPORTED SHE PLACED A SIZE 6 IN THE PT AND THERE WERE IMMEDIATE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY 4DCT TRACHEOSTOMY TUBE BTO COVIDIEN/FORMERLY TYCO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention