BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY DISPOSABLE CANNULA

    MDR report key: 1130804 · Received August 20, 2008

    Report

    Report Number
    2936999-2008-00383
    Event Type
    Death
    Date Received
    August 20, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 29, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTH
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUBE WAS NOT AVAILABLE FOR FAILURE INVESTIGATION. THE LOT NUMBER IS UNKNOWN. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER. NOTE: SUBCUTANEOUS EMPHYSEMA IS NOT USUALLY RELATED TO ANY DEFECT IN THE TRACHEOSTOMY TUBE, BUT MORE TO TRACHEOSTOMY MANAGEMENT. NOTE: THE MANUFACTURER'S DIRECTIONS FOR USE STATES: UNDER INSERTION: SECURE THE TRACHEOSTOMY TUBE TO THE PT USING THE NECK STRAP PROVIDED. NOTE: THE MANUFACTURER'S DIRECTIONS FOR USE STATES: UNDER WARNINGS: UNDER NO CIRCUMSTANCES SHOULD MORE THAN 25 MM OF MERCURY AIR PRESSURE BE USED TO INFLATE THE CUFF. OVER-INFLATION OF THE CUFF MAY CAUSE TRACHEAL DAMAGE AND MAY INHIBIT VENTILATION. AS A FURTHER PRECAUTION FOR VENTILATOR-DEPENDENT PATIENTS, CUFF INFLATION SHOULD BE CHECKED ON A REGULAR BASIS AND REPLACEMENT TRACHEOSTOMY TUBES SHOULD BE KEPT AT BEDSIDE. THE SHILEY DISPOSABLE INNER CANNULA PROVIDED IN THIS PACKAGE CAN ONLY BE REPLACED BY A SHILEY DISPOSABLE INNER CANNULA (DIC) OF THE SAME SIZE NUMBER. A DISPOSABLE INNER CANNULA (DIC) SHOULD BE WITH THE PT AT ALL TIMES. IN THE EVENT OF RESPIRATORY DISTRESS, THE DISPOSABLE INNER CANNULA (DIC) MUST BE INSERTED TO MECHANICALLY VENTILATE THE PT. DURING AND AFTER ATTACHMENT OF RESPIRATORY OR ANESTHESIA TUBING AND/OR CONNECTORS TO THE DISPOSABLE INNER CANNULA, AVOID APPLICATION OF EXCESSIVE ROTATIONAL, LINEAR, OR ROCKING FORCES ON THE TUBING AND/OR CONNECTORS TO PREVENT ACCIDENTAL DISCONNECTION OF THE DISPOSABLE INNER CANNULA, OR DAMAGE TO THE TRACHEOSTOMY TUBE.

    Description of Event or Problem · 1

    THE CALLER REPORTED A TRACHEOSTOMY TUBE BECAME DISLODGED AND THE PT HAD EXCESSIVE EDEMA DUE TO THE PRODUCT BEING DISLODGED. THE CALLER REPORTED HAD AN INCIDENT THE PREVIOUS AFTERNOON IN WHICH A PT WHO HAD BEEN "TRACHED" ONE WEEK AGO AND HAD AN 8DCT INSERTED, STARTED TO DEVELOP SUBCUTANEOUS EMPHYSEMA OF THE NECK AND FACE. THE PT WAS BEING VENTILATED IN THE INTENSIVE CARE UNIT. THE SUBCUTANEOUS EMPHYSEMA PROGRESSED AND THE PT STARTED TO HAVE RESPIRATORY DIFFICULTY. THE TRACHEOSTOMY TUBE WAS REMOVED AND THE PT WAS INTUBATED WITH AN UNSPECIFIED MANUFACTURER AND MODEL "STANDARD ENDOTRACHEAL TUBE". THE PT EXPIRED LATER IN THE DAY. THE CALLER COULD NOT PROVIDE ANY ADDITIONAL INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R