BEUDAMED
    FDA Adverse Event Death Summary report: N

    DISPOSABLE CANNULA CUFFED TRACHEOSTOMY

    MDR report key: 1656768 · Received April 8, 2010

    Report

    Report Number
    2936999-2010-00659
    Event Type
    Death
    Date Received
    April 8, 2010
    Date of Event
    March 13, 2010
    Report Date
    March 24, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDICAL DOCTOR PERFORMING THE PROCEDURE INDICATED "THAT THE TUBE DID NOT SEEM TO BE THE ISSUE, BUT MORE SO THE SHILEY TUBE AND THE COOK CATHETER (RHINO KIT) AND THE INABILITY TO PULL THE TUBE OFF THE INTRODUCER". THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WILL BE PERFORMED.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT THAT WHEN THE SHILEY 6DCT WAS INTRODUCED OVER THE COOK PERC TRACK INTRODUCER, THE PHYSICIAN COULD NOT PULL THE INTRODUCER OUT. FORCE WAS REQUIRED TO TRY TO REMOVE THE INTRODUCER AND SUBSEQUENTLY, THE SHILEY 6DCT BROKE AT THE FLANGE. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE CANNULA CUFFED TRACHEOSTOMY TRACHEOSTOMY TUBE JOH COVIDIEN, FORMERLY TYCO 0910000981

    Patients

    Seq Age Sex Outcome Treatment
    1 Death COOK RHINO KIT