BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH SLICK SET 8.0MM CUFFED ET TUBE

    MDR report key: 1061521 · Received June 17, 2008

    Report

    Report Number
    8040412-2008-00007
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    February 29, 2008
    Report Date
    June 11, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WILL NOT BE RETURNED TO THE MFR. A FOLLOW UP REPORT WILL FOLLOW IF MORE INFO BECOMES AVAILABLE. THE MFR WILL CONTINUE TO TRACK AND TREND FOR SIMILAR INCIDENTS.

    Description of Event or Problem · 1

    INCIDENT REPORTED AS: RESCUE PERSONNEL RESPONDED TO A TRAUMA CALL AND FOUND THE PT ALREADY IN CARDIO-PULMONARY ARREST. THE PT WAS INTUBATED AND PLACEMENT CONFIRMED WITH MULTIPLE DEVICES. ON ARRIVAL AT THE ED, THE PT WAS REASSESSED AND THE CREW NOTED AIR COMING FROM THE PT'S MOUTH. IT WAS NOTICED THE PILOT BALLOON WAS DEFLATED AND AN ATTEMPT WAS MADE TO REINFLATE WITH AIR, BUT WAS UNSUCCESSFUL. WHEN THE ET TUBE WAS REMOVED, IT WAS FOUND TO HAVE A RUPTURED CUFF. PATIENT WAS REINTUBATED WITHOUT INCIDENT. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1