BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EB CARLENS W/CARINA HOO

    MDR report key: 6076518 · Received November 3, 2016

    Report

    Report Number
    8040412-2016-00249
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    July 26, 2016
    Report Date
    October 26, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION OF THIS COMPLAINT IS IN PROGRESS AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    QN#(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 RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND NO DEFECTS WERE OBSERVED. THE CUFF PRESSURE WAS THEN TESTED BY INFLATING THE CUFFS TO 25 MBAR USING A CALIBRATE ENDO TEST METER. IT WAS OBSERVED THAT THE BLUE CUFF COULD BE INFLATED WITHOUT ANY DIFFICULTIES; HOWEVER, THE CLEAR CUFF COULD NOT MAINTAIN PRESSURE. THE SAMPLE WAS IMMERSED INTO A WATER BATH WITH BOTH CUFFS INFLATED AND IT WAS OBSERVED THAT AIR BUBBLES WERE COMING FROM THE CLEAR CUFF. CLOSER INSPECTION OF THE LEAKAGE AREA REVEALED THAT THERE WAS A CUT MARK ON THE SURFACE OF THE CUFF. THE COMPLAINT OF "BLUE CUFF LEAKING PRIOR TO USE" COULD NOT BE CONFIRMED AS THERE WERE NO ISSUES FOUND WITH THE BLUE CUFF ON THE RETURNED SAMPLE. THE CUT MARK ON THE CLEAR CUFF COULD BE CAUSED DURING HANDLING OF THE PRODUCT BY THE USER. A 100% LEAK TEST IS PERFORMED AT THE MANUFACTURING FACILITY; THEREFORE, A DEFECT OF THIS TYPE WOULD BE DETECTED PRIOR TO RELEASE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT THE DOCTOR "FOUND BLUE CUFF LEAKAGE PRIOR TO USE ON PATIENT DURING FUNCTIONAL TEST."

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT THE DOCTOR "FOUND BLUE CUFF LEAKAGE PRIOR TO USE ON PATIENT DURING FUNCTIONAL TEST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727900 RUSCH EB CARLENS W/CARINA HOO BRONCHIAL TUBE BTS TELEFLEX MEDICAL 13IT16

    Patients

    Seq Age Sex Outcome Treatment
    1