BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-GUIDE ENDOTRACHEAL TUBE INT

    MDR report key: 21169949 · Received January 16, 2025

    Report

    Report Number
    MW5164824
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    January 9, 2025
    Report Date
    January 10, 2025
    Manufacturer
    GREEN FIELD MEDICAL SOURCING, INC/XPONENT HEALTHCARE INC
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT (PT) WAS INTUBATED WITH AN 8.0 ENDOTRACHEAL TUBE (ETT) TUBE FOR A GENERAL ANESTHESIA CASE. A BOUGIE WAS PLACED THROUGH THE ENDOTRACHEAL TUBE (ETT) TO PROTECT THE AIRWAY, SINCE THE ENDOTRACHEAL TUBE (ETT) WAS NOT COMPLETELY THROUGH THE VOCAL CORDS YET. THIS INTUBATION WAS NOT TRAUMATIC. ONCE THE ENDOTRACHEAL TUBE (ETT) WAS FULLY INTUBATED INTO THE TRACHEA, THE BOUGIE WAS REMOVED WITHOUT DIFFICULTY. ONCE DOCTOR VISUALIZED THE INTERNAL LUMEN OF THE ENDOTRACHEAL TUBE (ETT) WITH THE BRONCHOSCOPE, WE NOTICED A PIECE OF THE BOUGIE HAD BROKEN OFF INTO THE PATIENT'S ENDOTRACHEAL TUBE (ETT). DOCTOR SUCCESSFULLY REMOVED ALL OF THE PIECES OF THE BOUGIE FROM THE ENDOTRACHEAL TUBE (ETT)/AIRWAY, CONFIRMING NO PIECES WERE LEFT INSIDE THE AIRWAY VIA DIRECT VISUALIZATION FROM THE BRONCHOSCOPE. THE BOUGIE WAS IN 4 PIECES ONCE REMOVED AND WAS SAVED FOR FUTURE INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111265 FLEX-GUIDE ENDOTRACHEAL TUBE INT STYLET, TRACHEAL TUBE BSR GREEN FIELD MEDICAL SOURCING, INC/XPONENT HEALTHCARE INC GM85110 139202

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female