BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUSELECT REPLACEMENT INNER CANNULA

    MDR report key: 24631410 · Received March 18, 2026

    Report

    Report Number
    3012307300-2026-02674
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 1, 2026
    Report Date
    March 18, 2026
    Manufacturer
    ICU MEDICAL CZECH REPUBLIC A. S
    Product Code
    BTO
    UDI-DI
    15019517076653
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: 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 CRACKS WERE OBSERVED IN THE WINDOWS. THE PATIENT GOR AL (MALE, BIRTH: 01/05/1958, 68 KG), THE DEFECT INVOLVED AN INCIDENTAL DISCOVERY OF BROKEN INNER CANNULAS DURING THE SWITCH BETWEEN THE FENESTRATED AND NON-FENESTRATED CANNULA DURING VENTILATION SESSIONS. REGARDING CLINICAL IMPACT, NO TRACHEAL LESIONS OR DIRECT PATIENT HARM WERE OBSERVED, AS THE AREA WAS PROTECTED BY THE OUTER CANNULA. HOWEVER, THE ISSUE LED TO FORCED HOSPITAL RETURNS FOR ASSESSMENT AND PREMATURE CANNULA REPLACEMENT BEFORE THE 29-DAY REGULATION PERIOD TO AVOID INFECTIOUS/TRAUMATIC RISKS AND UNNECESSARY FINANCIAL COSTS. NO MEDICAL TREATMENT OR INTERVENTION WAS REQUIRED. THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687384 PORTEX BLUSELECT REPLACEMENT INNER CANNULA TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO ICU MEDICAL CZECH REPUBLIC A. S 15019517076653

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male