BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 1665723 · Received April 20, 2010

    Report

    Report Number
    2936999-2010-00733
    Event Type
    Injury
    Date Received
    April 20, 2010
    Date of Event
    March 1, 2009
    Report Date
    April 19, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TUBE LASTED FROM (B) (6) 2009 TO (B) (6) 2009 (21 DAYS) AND THAT THE PT STATED WHILE EXERCISING, SHE STARTED TO FEEL PRESSURE IN HER TRACHEA LIKE THE AIR WAS BEING CUT OFF. THE PT CHECKED THE PILOT BALLOON AND DISCOVERED THAT IT WAS FILING UP WITH AIR ON IT'S OWN. THE PT HAD TO PERFORM AN EMERGENCY TRACHEOSTOMY TUBE CHANGE WHICH WAS DIFFICULT AS THE CUFF KEPT INFLATING AS SHE WAS TRYING TO REMOVE THE AIR IN ORDER TO REMOVE THE TUBE FROM HER STOMA. THE PT REPORTED HAVING HAD GREAT DIFFICULTY INSERTING THE NEW TUBE WHICH RESULTED IN BLEEDING AND SPASM OF HER STOMA AND SHE ALSO COMPLAINED ON "TOXIC FUMES" FROM THIS TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 0705002182

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention