BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 8084294 · Received November 19, 2018

    Report

    Report Number
    8020889-2018-00126
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    October 25, 2018
    Report Date
    February 22, 2019
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US WITH 510(K) NUMBER K771219. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE SAMPLE RETURNED FOR EVALUATION. ALSO RETURNED WERE TWO SUCTIONS. THE DEVICE FAILED TO MEET SPECIFICATION AS IT WAS RECEIVED OR MADE AVAILABLE FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED SAMPLE SHOWS SOME AIR CONTAINED IN THE BRONCHIAL CUFF, AIR WAS REMOVED, AND THE RETURNED SAMPLE WAS INFLATED USING THE PARAMETERS SET OUT. THE BRONCHIAL CUFF INFLATED WITHOUT ANY ISSUE, BUT THE TRACHEAL CUFF FAILED TO REMAIN INFLATED. THE BRONCHIAL WAS DEFLATED AND NO ISSUE NOTED. THE RETURNED SAMPLE WAS LEAK TESTED UNDER WATER AND LEAKAGE WAS DETECTED FROM THE TRACHEAL CUFF BODY. FURTHER EXAMINATION OF THE TRACHEAL CUFF SHOWS A C SHAPED TEAR TO THE CUFF BODY. THE SINGLE WALL THICKNESS OF THE CUFF WAS MEASURED AWAY FROM THE DAMAGED AREA AND FOUND TO MEET OUR BLUEPRINT SPECIFICATIONS. THE REPORTED DEFECT COULD BE DETECTED ON THE RETURNED SAMPLE. INFORMATION HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, A LEAK WAS FOUND IN THE WHITE AIR BAG. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923870 MALLINCKRODT TUBE, BRONCHIAL (W/WO CONNECTOR) BTS MALLINCKRODT MEDICAL 126-37 201612033X

    Patients

    Seq Age Sex Outcome Treatment
    1