BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGT ORAL CUFFED ET 3.5MM

    MDR report key: 6907980 · Received October 2, 2017

    Report

    Report Number
    8040412-2017-00211
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    July 6, 2017
    Report Date
    September 14, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    PMA / PMN Number
    K931163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE SAMPLE WAS NOT RETURNED; THEREFORE, ONE SAMPLE WAS CHOSEN FROM CURRENT PRODUCTION AT THE MANUFACTURING FACILITY FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND NO OBVIOUS DEFECTS WERE OBSERVED. THE CUFF PRESSURE OF THE CURRENT PRODUCTION REPRESENTATIVE SAMPLE WAS THEN INFLATED TO 25MBAR USING A CALIBRATED ENDOTEST. THE CUFF PRESSURE WAS OBSERVED TO BE MAINTAINED AT 25MBAR FOR AT LEAST 30 MINUTES. THE REPRESENTATIVE SAMPLE WAS THEN IMMERSED INTO THE WATER FOR LEAK TESTING. NO BUBBLES WERE OBSERVED FLOWING OUT FROM THE SAMPLE DURING THE UNDERWATER TEST INDICATING THERE WERE NO LEAKS. THE COMPLAINT COULD NOT BE CONFIRMED. THE ACTUAL SAMPLE IS NEEDED TO PERFORM A PROPER INVESTIGATION AND TO DETERMINE A ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "LEAK NOTED DURING VENTILATION." NO REPORT OF PATIENT CONSEQUENCE OR INJURY.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "LEAK NOTED DURING VENTILATION." NO REPORT OF PATIENT CONSEQUENCE OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687647 AGT ORAL CUFFED ET 3.5MM TUBE, TRACHEAL (W/WO CONNECTOR BTR TELEFLEX MEDICAL 16KG06

    Patients

    Seq Age Sex Outcome Treatment
    1