BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE, TRACHEAL (W/WO CONNECTOR)

    MDR report key: 7052852 · Received November 22, 2017

    Report

    Report Number
    8040459-2017-05023
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    October 30, 2017
    Report Date
    November 22, 2017
    Manufacturer
    KENDALL GAMMATRON, THAILAND
    Product Code
    BTR
    Adverse Event
    Yes
    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 - 510(K) NUMBER K892432. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A COMMUNICATION REGARDING CUFF BREAKAGE. THE CUSTOMER REPORTED THAT THEY DISCOVERED AN AIR BAG LEAK AND SO REMOVED THE TRACHEAL TUBE AND REPLACED IT WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832185 TUBE, TRACHEAL (W/WO CONNECTOR) BTR KENDALL GAMMATRON, THAILAND 9475E 1708035FED

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention