BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORTEX TUBES PDT UNIPERC

    MDR report key: 23008108 · Received September 9, 2025

    Report

    Report Number
    3012307300-2025-10460
    Event Type
    Death
    Date Received
    September 9, 2025
    Date of Event
    August 1, 2025
    Report Date
    October 7, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED FOR EVALUATION OF COMPLAINT OF TRACHEOSTOMY DISPLACEMENT. THE CUSTOMER REPORTED A POTENTIAL ISSUE RELATED TO THE FLANGE LOCKING MECHANISM. NO TESTS WERE PERFORMED BECAUSE NO SAMPLE WAS PROVIDED. WITHOUT SAMPLE, PHOTO OR VIDEO WE ARE UNABLE TO FURTHER INVESTIGATE AND CONFIRM THIS COMPLAINT AND THE ROOT CAUSE REMAINS UNKNOWN. NO SIGNAL OF CONFIRMED COMPLAINTS IN RELATION WITH THIS ISSUE WAS IDENTIFIED. NO DEVICE HISTORY OR LOT HISTORY REVIEW WERE PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    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 TRACHEOSTOMY WAS DISPLACED INCLUDING SOME HARM AT THE TIME OF DISLODGEMENT, PROGRESSING TO DEATH TO THE PATIENT IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2843796 PORTEX TUBES PDT UNIPERC TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO ICU MEDICAL, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death