BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 6930341 · Received October 9, 2017

    Report

    Report Number
    8020889-2017-05156
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    September 18, 2017
    Report Date
    December 11, 2017
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED FOR ANALYSIS AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. VISUAL ANALYSIS AND AN INFLATION/DEFLATION TEST WAS PERFORMED, AIR WAS APPLIED TO THE CUFF AND IT WAS OBSERVED THE CUFF HELD THE AIR AND NO DEFORMATIONS OR ANOMALIES WERE OBSERVED. THE SAMPLE WAS SUBMERGED INTO A CONTAINER FILLED WITH WATER AND NO LEAKS WERE OBSERVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 - 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 REGARDING A SITUATION THAT OCCURRED BEFORE SURGERY. ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF LEAK. IT WAS REPORTED THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710318 MALLINCKRODT TUBE, BRONCHIAL (W/WO CONNECTOR) BTS MALLINCKRODT MEDICAL 126-37 201612329X

    Patients

    Seq Age Sex Outcome Treatment
    1