BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED TRACHEAL TUBE

    MDR report key: 11086695 · Received December 29, 2020

    Report

    Report Number
    2936999-2020-00981
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    August 13, 2020
    Report Date
    December 29, 2020
    Manufacturer
    BICAKCILAR GLOBAL TIBBI URUNLER AS
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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, THE DEVICE HAD A CUFF LEAK. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555737 UNSPECIFIED TRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR BICAKCILAR GLOBAL TIBBI URUNLER AS UNSPECIFIED TRACHEAL TUBE

    Patients

    Seq Age Sex Outcome Treatment
    1