BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL

    MDR report key: 24634088 · Received March 18, 2026

    Report

    Report Number
    3012307300-2026-02656
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    December 22, 2025
    Report Date
    March 18, 2026
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V
    Product Code
    BTR
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 9617604-2026-00002-00. THE DATE OF THAT SUBMISSION WAS 15-JAN-2026. H3: THE DEVICE WAS RECEIVED FOR EVALUATION. LOT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. VISUAL INSPECTION FOUND NO DAMAGE OR ANOMALIES. FUNCTIONAL TESTING CONFIRMED THE REPORTED ISSUE, AS THE CUFF WAS UNABLE TO HOLD AIR AND LEAKAGE WAS OBSERVED DURING SUBMERSION TESTING. FURTHER INSPECTION IDENTIFIED A LARGE TEAR ON THE CUFF SURFACE. THE ROOT CAUSE COULD NOT BE DETERMINED. NO REPAIR WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE EXCHANGING FOR A TRACHEOSTOMY TUBE, A LEAK WAS DISCOVERED. DURING USE, THERE WAS ALSO VOICE LEAKAGE DURING TRACHEAL SUCTIONING. THE LEAK IS OCCURRING FROM THE CENTER OF THE CUFF. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689202 PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL TUBE, TRACHEAL (W/WO CONNECTOR) BTR ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown