BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 7469087 · Received April 27, 2018

    Report

    Report Number
    8020889-2018-00050
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    April 18, 2018
    Report Date
    April 27, 2018
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH 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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, PREOPERATIVE, THE DEVICE SHOWED DOUBLE CAVITY BALLOON LEAKAGE. THE CUSTOMER ALSO REPORTED THAT THE CUFF RUPTURED. THE CUSTOMER REPORTED NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312445 MALLINCKRODT TUBE, BRONCHIAL (W/WO CONNECTOR) BTS MALLINCKRODT MEDICAL 126-37 1201703192X

    Patients

    Seq Age Sex Outcome Treatment
    1