BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUCTIONAID PROFILE TRACHEOSTOMY TUBE

    MDR report key: 947739 · Received November 8, 2007

    Report

    Report Number
    1217052-2007-00149
    Event Type
    Death
    Date Received
    November 8, 2007
    Date of Event
    April 25, 2006
    Report Date
    October 29, 2007
    Manufacturer
    SMITHS MED INT'L LTD
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMITHS MEDICAL INT'L LTD. HAS BEEN NOTIFIED OF AN EVENT THAT IT WAS REPORTED THAT A PT IN RECOVERY FOR A BRAIN INFARCT/ANEURYSM OF AORTA HAD A SUBSEQUENT OPERATION FOR NARROWING OF THE AIRWAY. IT WAS NOTED THAT THE SUCTION CATHETER COULD NOT BE FULLY INSERTED, HOWEVER, THE PT WAS BREATHING SPONTANEOUSLY. THE PT'S SP02 DROPPED, ASPHYXIA CAUSED BY PHLEGM WAS SUSPECTED; HOWEVER, SUCTIONING OF THE AIRWAY PRODUCED LITTLE PHLEGM. THE TUBE WAS REMOVED, CHECKED FOR OCCLUSION AND REINSERTED AS CLEAR. MANUAL RESPIRATION WITH AN AMBULATORY MASK WAS CONDUCTED; HOWEVER, SIGNIFICANT RESISTANCE WAS MET. THE SUCTIONAID TUBE WAS REMOVED AND REPLACED WITH ONE SIZE SMALLER TUBE. THE HOSP PERFORMED BRONCHOSCOPY BUT WAS UNABLE TO CONFIRM PLACEMENT. PT DIED. EVENT OCCURRED IN ANOTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTIONAID PROFILE TRACHEOSTOMY TUBE 73 JOH - BREATHING TUBE JOH SMITHS MED INT'L LTD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death BRONCHOSCOPE| KOKEN BRANCH SPEECH CANNULA (PC # 3405)