BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE LARYNGEAL TUBE, DUAL LUMEN

    MDR report key: 16722304 · Received April 12, 2023

    Report

    Report Number
    3012307300-2023-03974
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Date of Event
    March 12, 2023
    Report Date
    June 2, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: D10: DATE AVAILABLE AND H6: EVALUATION CODES: UPDATED DEVICE EVALUATION: TWO USED AND THREE UNUSED SAMPLES WERE RECEIVED FOR INVESTIGATION. VISUAL INSPECTION CONFIRMED THE COMPLAINT, THERE WERE TEARS IN THE CUFFS. THE CAUSE WAS ATTRIBUTED TO A SUPPLIED ITEM FAULT. A DEVICE HISTORY REPORT (DHR) REVIEW COULD NOT BE COMPLETED BECAUSE THE DHR IS AT THE SUPPLIER. THE ITEMS WILL BE SENT TO THE SUPPLIER FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    LOT NUMBER AND UDI SECTION ARE UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. DEVICE HAS NO SALES IN THE US. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE PRE-USE CHECK, THE PRODUCT WAS USED FOR A PATIENT IN CARDIOPULMONARY ARREST. AFTER INTUBATION, THE CUSTOMER PUT AIR INTO THE CUFF, BUT THE PILOT BALLOON WOULD NOT INFLATE. SO THE CUSTOMER REMOVED THE PRODUCT FROM THE PATIENT AND INTUBATED ANOTHER NEW ONE, BUT THE SAME EVENT OCCURRED. THEN THE DEVICE WAS CHANGED TO ONE WITH LARGER SIZE (NO.4) AND INTUBATED IT TO THE PATIENT USING THE SAME PROCEDURE, AND A PROPER VENTILATION WAS OBSERVED. THE PATIENT HAD ONLY ONE DOUBLE TOOTH ON THE UPPER FRONT RIGHT SIDE AND HAD NO OTHER TEETH. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT. (B)(6) DOCUMENTS THE FIRST PRODUCT MALFUNCTION AND CC-192495 DOCUMENTS THE SECOND PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241768 DISPOSABLE LARYNGEAL TUBE, DUAL LUMEN TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown