BEUDAMED
    FDA Adverse Event Other Summary report: N

    RUSCH SLICK SET ENDOTRACHEAL TUBE 8.0

    MDR report key: 1010246 · Received March 5, 2008

    Report

    Report Number
    MW5005840
    Event Type
    Other
    Date Received
    March 5, 2008
    Date of Event
    February 21, 2008
    Report Date
    March 5, 2008
    Manufacturer
    RUSCH, TELEFLEX MEDICAL COMPANY
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON THE ABOVE MENTIONED DATE SLCFD RESCUE 2 RESPONDED TO A TRAUMA CALL AND FOUND THE PT IN CARDIAC ARREST. THE PT WAS INTUBATED AND PLACEMENT CONFIRMED WITH MULTIPLE DEVICES. ON ARRIVAL AT THE ED AND WHILE REASSESSING THE PT, THE CREW NOTED AIR COMING FROM THE PT'S MOUTH. THE RESCUE CREW NOTICED THAT THE PILOT BALLOON WAS DEFLATED AND ATTEMPTED TO ADD 10CC OF AIR AND WAS UNSUCCESSFUL. THE Y NOTIFIED THE ER PHYSICIAN AND THE PT WAS EXTUBATED AND REINTUBATED BY THE ER PHYSICIAN. WHEN THE ET TUBE WAS REMOVED IT WAS FOUND TO HAVE A RUPTURED CUFF. THIS IS THE FIRST REPORTED INCIDENT WITH A RUPTURED CUFF AND WE HAVE BEEN USING THESE PARTICULAR ET TUBES FOR MANY YRS. THE PRODUCT AND PRODUCT PACKAGING IS NOT AVAILABLE FOR INSPECTION DUE TO BIOHAZARD CONTAMINATION. DIAGNOSIS OR REASON FOR USE: PT FOUND IN CARDIOPULMONARY ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH SLICK SET ENDOTRACHEAL TUBE 8.0 ET TUBE BTR RUSCH, TELEFLEX MEDICAL COMPANY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other