BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TRACHEOSTOMY TUBE

    MDR report key: 24002907 · Received January 8, 2026

    Report

    Report Number
    3012307300-2026-00218
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    January 8, 2025
    Report Date
    January 8, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    JOH
    UDI-DI
    15021312006070
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 1824231-2025-00013-00. THE DATE OF THAT SUBMISSION WAS (12-FEB-2025). ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE REPORTED ISSUE WAS CONFIRMED DURING VISUAL INSPECTION, WHICH VERIFIED THE REPORTED CONDITION. HOWEVER, THE INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE OBSERVED PARTICULATES. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MOLD WAS FOUND IN THE TRACHEAL CANNULA WHILE IT WAS BEING REMOVED. THE CANNULA WAS REUSABLE AND WAS REPROCESSED UP TO 10 TIMES. PRIOR TO INSERTION, THE TRACHEAL CANNULA HAD BEEN CLEANED AND STORED AS INSTRUCTED BY THE PROVIDER AND IN ACCORDANCE WITH THE USER INSTRUCTIONS. THERE WERE NO HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65157 BIVONA TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH ICU MEDICAL, INC. 4321558 15021312006070

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male