BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED TRACHEAL TUBE

    MDR report key: 12867699 · Received November 24, 2021

    Report

    Report Number
    2936999-2021-01139
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    October 31, 2021
    Report Date
    November 24, 2021
    Manufacturer
    BICAKCILAR GLOBAL TIBBI URUNLER AS
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE DEVICE'S STITCH HOLES (FLANGE) RIPPED WHEN SUTURES WERE SECURED THROUGH THEM. A NEW TRACHEOSTOMY TUBE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769710 UNSPECIFIED TRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR BICAKCILAR GLOBAL TIBBI URUNLER AS UNSPECIFIED TRACHEAL TUBE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown