BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED TRACHEAL TUBE

    MDR report key: 14224044 · Received April 27, 2022

    Report

    Report Number
    2936999-2022-00353
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    February 22, 2022
    Report Date
    April 27, 2022
    Manufacturer
    BICAKCILAR GLOBAL TIBBI URUNLER AS
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    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, DURING SURGERY, THREE ENDOTRACHEAL TUBES WERE USED TO INTUBATE A NEONATE. ATTEMPTED TO INTUBATE FIVE TIMES AND VERIFIED PLACEMENT VIA X-RAY. SURFACTANT WAS GIVEN THROUGH THE ENDOTRACHEAL TUBE BUT ONLY ONE DOSE WAS ABLE TO BE GIVEN, SECOND DOSE WAS CLOGGED IN THE TUBE. THE TUBE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997343 UNSPECIFIED TRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR BICAKCILAR GLOBAL TIBBI URUNLER AS UNSPECIFIED TRACHEAL TUBE 30111387

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown