BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED TRACHEAL TUBE

    MDR report key: 11744559 · Received April 29, 2021

    Report

    Report Number
    2936999-2021-00385
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 12, 2021
    Report Date
    April 29, 2021
    Manufacturer
    BICAKCILAR GLOBAL TIBBI URUNLER AS
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    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, THE DEVICE HAD A CUFF LEAK. THERE WAS NO ALLEGATION OF PATIENT DEATH OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641025 UNSPECIFIED TRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR BICAKCILAR GLOBAL TIBBI URUNLER AS UNSPECIFIED TRACHEAL TUBE 20J0059JZX

    Patients

    Seq Age Sex Outcome Treatment
    1