BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX, BIVONA UNCUFFED NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 22726187 · Received August 6, 2025

    Report

    Report Number
    3012307300-2025-09340
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    September 9, 2024
    Report Date
    August 6, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    BTO
    UDI-DI
    15021312005684
    PMA / PMN Number
    K083641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: NO PRODUCT WAS RECEIVED FOR ANALYSIS. THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER 4221354 WAS REVIEWED, AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. WITHOUT THE RETURN OF THE PRODUCT A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLANGE OF THE TRACHEOSTOMY TUBE WAS BROKEN; THEREFORE, THE TRACHEOSTOMY TUBE MIGHT NOT REMAIN PROPERLY POSITIONED IN THE TRACHEA. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533119 PORTEX, BIVONA UNCUFFED NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4221354 15021312005684

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown