BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL

    MDR report key: 21994068 · Received May 9, 2025

    Report

    Report Number
    3012307300-2025-05435
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    January 27, 2025
    Report Date
    June 23, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    BTR
    UDI-DI
    15019315022340
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER 4212088 WAS REVIEWED, AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. WITHOUT THE RETURN OF THE USED SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DOCTOR TRIED TO INTUBATE THE PATIENT. THE PILOT BALLOON AND CUFF DEFLATED AFTER 10 CC OF AIR WAS INJECTED. THIS OCCURRED IN THE HOSPITAL AND WAS OPERATED BY A HEALTH PROFESSIONAL. THIS OCCURRED DURING PATIENT USE, AND THERE WAS NO HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998553 PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4212088 15019315022340

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown