BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL

    MDR report key: 22643192 · Received July 29, 2025

    Report

    Report Number
    9617604-2025-00240
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 9, 2025
    Report Date
    October 1, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    BTR
    UDI-DI
    15019315022326
    PMA / PMN Number
    K790312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INCORRECTLY FILED UNDER THIS REGISTRATION NUMBER, PLEASE REFERENCE MRN 3012307300-2025-11116-00 FOR DETAILS PERTINENT TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    H3: NO PRODUCT WAS RETURNED BUT A VIDEO WAS ATTACHED FOR EVALUATION. THE CUSTOMER ISSUE WAS CONFIRMED AS THE VIDEO SHOWED EVIDENCE OF TESTING PER MP 3027. NO OTHER ANALYSIS CAN BE CARRIED OUT SINCE THERE WAS NO RETURNED PRODUCT.

    Description of Event or Problem · 0

    IT WAS STATED IN THE REPORT THAT THERE WAS AN AIR LEAK FROM THE CUFF OF THEIR SIZE 7 100/199/070 ET TUBE. PER REPORTER, THE LEAK WAS AT THE BASE AND THE CUFF WAS NOT PERFORATED. A VIDEO WAS PROVIDED DEMONSTRATING THE LEAK BY IMMERSING THE ET TUBE IN WATER AND INFLATING THE CUFF ¿ BUBBLES SEEN. THERE WAS NO PATIENT HARM, BUT THE PATIENT NEEDED TO BE REINTUBATED. THE SAMPLE WAS CONTAMINATED AND UNAVAILABLE FOR RETURN. THEY HAVE ONE REMAINING UNOPENED ET TUBE OF THE SAME BATCH AND HAS BEEN QUARANTINED IN CASE THERE IS AN ISSUE. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267505 PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6010564 15019315022326

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown