BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUSELECT TRACHEOSTOMY TUBE

    MDR report key: 19472798 · Received June 5, 2024

    Report

    Report Number
    3012307300-2024-04573
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    April 20, 2024
    Report Date
    July 15, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    UDI-DI
    15019517076172
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE AFFECTED DEVICE WAS RECEIVED FOR EVALUATION. UNDER VISUAL INSPECTION IT WAS OBSERVED THAT THE INFLATION LINE WAS DETACHED FROM PILOT BALLOON. ROOT CAUSE ANALYSIS WAS NOT ESTABLISHED. THIS ISSUE WAS ESCALATED TO CAPA-000905. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PILOT BALLOON AND TUBING WERE TORN. THE EVENT OCCURRED DURING USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859206 PORTEX BLUSELECT TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD, INC. 4306063 15019517076172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown