BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY

    MDR report key: 1746180 · Received June 30, 2010

    Report

    Report Number
    2936999-2010-00977
    Event Type
    Death
    Date Received
    June 30, 2010
    Date of Event
    October 21, 2009
    Report Date
    June 21, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK AND THEREFORE, THE MANUFACTURE DATE OF THE DEVICE CANNOT BE DETERMINED. NO ANALYSIS OR CONCLUSIONS CAN BE MADE WITHOUT THE DEVICE.

    Description of Event or Problem · 1

    ON 06/21/2010, A COMPLAINT DATED (B) (6) 2010 WAS RECEIVING VIA E-MAIL FROM A LAW OFFICE REPORTING A PATIENT'S DEATH AND USE OF AN UNSPECIFIED SIZE, MODEL AND LOT NUMBER TRACHEOSTOMY TUBE. IT WAS REPORTED THAT A PATIENT, (B) (6), DIED ON (B) (6) 2009 AT (B) (6) HOSPITAL. IT IS ALLEGED THAT THE TRACHEOSTOMY TUBE MALFUNCTIONED WITH AN AIR LEAK COMING THROUGH THE TRACHEOSTOMY SITE. THE PATIENT WAS BROUGHT TO THE (B) (6) EMERGENCY ROOM (B) (6) 2009 WITH PNEUMONIA; TEMPERATURE OF 103; SIGNIFICANT HYPOXEMIA AND WAS REPORTEDLY INTUBATED BY THE ER PHYSICIAN AND SUBSEQUENTLY TRANSFERRED TO THE ICU FOR RESPIRATORY FAILURE, ARDS AND BILATERAL PNEUMONIA. ON (B) (6) 2009, THE PATIENT TESTED POSITIVE FOR (B) (6). ON (B) (6) 2009, A TRACHEOSTOMY AND BRONCHOSCOPY WERE PERFORMED. IT WAS REPORTED THAT FOR SEVERAL DAYS AFTER THE TRACHEOSTOMY WAS PERFORMED, THERE WAS EVIDENCE OF SUBCUTANEOUS EMPHYSEMA AROUND THE PATIENT'S NECK. AROUND 2:00 PM (B) (6) , IT WAS REPORTED THAT THE PATIENT'S PRIMARY TRACH DISLODGED AND A PHYSICIAN WAS CALLED TO REPLACE THE TRACH. ROUTINE TRACH CARE WAS PERFORMED AROUND 4:00 AM (B) (6) 2009 WITH TRACH TIES CHANGED, SUCTIONING OF TRACH AND REMOVAL OF INNER CANNULA. IT WAS REPORTED THAT PATIENT WAS ABLE TO SPEAK DURING THIS PROCESS. THE INNER CANNULA REPORTEDLY COULD NOT BE REINSERTED, THE PATIENT'S CHEST BEGAN TO SWELL AND THE PATIENT WAS REPOSITIONED. THE NURSE TRIED USING AN AMBU BAG THROUGH THE TRACH, SUBCUTANEOUS EMPHYSEMA CONTINUED TO WORSEN SPREADING TO FACE. PATIENT WAS ORALLY INTUBATED, SUBCUTANEOUS EMPHYSEMA MOVED FROM NECK, FACE, CHEST DOWN INTO ABDOMEN. PATIENT WENT INTO CARDIAC ARREST AND DIED (B) (6) 2009 AT 4:30 A.M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE JOH COVIDIEN, FORMERLY TYCO

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death| R