BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL

    MDR report key: 22542006 · Received July 18, 2025

    Report

    Report Number
    3012307300-2025-08529
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    June 23, 2025
    Report Date
    September 29, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    BTR
    UDI-DI
    15019315022340
    PMA / PMN Number
    K790312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D9 - PRODUCT RECEIVED DATE 8/4/2025. H3/H6 - TEST DATA. THREE PHOTOS WERE RECEIVED FOR EVALUATION FOR THE COMPLAINT THAT THE DEVICE HAD CUFF RUPTURE THAT REQUIRED EXTUBATION AND PATIENT SUDDENLY HAD AN AIR LEAK. THE VISUAL AND FUNCTIONAL TESTING WAS PERFORMED. IN ATTEMPTS TO REPLICATE CLINICAL USE, THE CUFF WAS INFLATED AS PER IFU USING AN ICU MEDICAL PROVIDED SYRINGE. THERE WERE NO DIFFICULTIES OBSERVED DURING INFLATION AND NO LEAKS OBSERVED. UNABLE TO CONFIRM CUSTOMER COMPLAINT OF CUFF RUPTURE, AIR LEAK.

    Additional Manufacturer Narrative · 0

    H3, H6: 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 INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD CUFF RUPTURE THAT REQUIRED EXTUBATION, AND PATIENT SUDDENLY HAD AN AIR LEAK. THERE WAS DELAY IN THERAPY. THE POTENTIAL LOT NUMBERS PROVIDED WERE 6066701 OR 6060042. EVENT OCCURRED DURING USE ON PATIENT, AND THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400197 PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL TUBE, TRACHEAL (W/WO CONNECTOR) BTR ICU MEDICAL, INC. NI 15019315022340

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention