BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 7026284 · Received November 13, 2017

    Report

    Report Number
    8020889-2017-05173
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 23, 2017
    Report Date
    March 5, 2018
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SAMPLE WAS RETURNED AND VISUAL EXAMINATION SHOWED THAT THE SHAPE RETURNED UNIT HAD BEEN ALTERED USING THE STYLET WIRE. THE STYLET WIRE WAS REMOVED AND INFLATION/DEFLATION TESTING WAS SUCCESSFUL. THERE WAS NO FAULT FOUND WITH THE DEVICE. THE PROBABLE ROOT CAUSE IS THAT THE CUFF TEST WAS CARRIED OUT WHEN THE SHAPE OF THE TUBE WAS INCORRECTLY ALTERED WITH THE STYLET WIRE. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A COMMUNICATION THAT DURING THE CUFF TEST, THE TRACHEAL CUFF WOULD NOT DEFLATE. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805821 MALLINCKRODT TUBE, BRONCHIAL (W/WO CONNECTOR) BTS MALLINCKRODT MEDICAL 126-37 201701457X

    Patients

    Seq Age Sex Outcome Treatment
    1