BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-GUIDE ENDOTRACHEAL TUBE INTRODUCER

    MDR report key: 21388955 · Received February 14, 2025

    Report

    Report Number
    3015966505-2025-00001
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    January 9, 2025
    Report Date
    February 10, 2025
    Manufacturer
    XPONENT HEALTHCARE INC.
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VOLUNTARY REPORT # MW5164824. INITIAL REPORT INFORMATION IS UNKNOWN AS THEY ASKED TO REMAIN CONFIDENTIAL ON THE VOLUNTARY REPORT. DUE TO THIS, ADDITIONAL INFORMATION ON THE EVENT CANNOT BE FOLLOWED UP ON AND UNABLE TO RETRIEVE THE DEVICE FOR EVALUATION. THERE IS NO UNIQUE DEVICE IDENTIFIER FOR THIS PRODUCT AS IT WAS NOT REQUIRED AT THE TIME OF MANUFACTURE. REVIEW OF LOT HISTROY 139202 FOR THE TRACHEAL TUBE INDICATED THAT THE DEVICE WAS USED (APPROXIMATELY 10 YEARS) PAST THE SHLEF LIFE OF THE PRODUCT. THE LOT WAS MANUFACTURED ON (SEPTEMBER 5, 2012) BY GREENFIELD MEDICAL SOURCING, INC. AT THE TIME OF MANUFACTURE, GREENFIELD MEDICAL SOURCING WAS NOT PUTTING AN EXPIRATION DATE ON THE NON-STERILE FLEX GUIDE ET TUBE INTRODUCER. GRRENFIELD MEDICAL SOURCING INDICTED THE PRODUCT HAS A 3 YEAR SHELF LIFE. THE USE OF DEVICE PAST ITS SHELF-LIFE MAY IMPACT ITS PERFORMANCE. XPONENT HEALTHCARE, INC. AQUIRED THE FLEX-GUIDE ENDOTRACHAEL TUBE INTRODUCER PRODUCT LINE FROM GREENFIELD MEDICAL SOURCING INC ON AUGUST 22, 2022.

    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
    1415084 FLEX-GUIDE ENDOTRACHEAL TUBE INTRODUCER STYLET, TRACHAEL TUBE BSR XPONENT HEALTHCARE INC. GM85110 139202

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention