BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX TUBES BLUSELECT

    MDR report key: 21775243 · Received April 4, 2025

    Report

    Report Number
    3012307300-2025-03779
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    December 1, 2024
    Report Date
    May 21, 2025
    Manufacturer
    SMITHS MEDICAL CZECH REPUBLIC A. S
    Product Code
    BTO
    UDI-DI
    15019517076226
    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

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 3011237704-2025-00024-00. THE DATE OF THAT SUBMISSION WAS 11-FEB-2025. B3: DAY OF EVENT IS UNKNOWN. H3: DEVICE NOT RECEIVED BY MANUFACTURER. 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

    ONE DEVICE WAS RETURNED FOR ANALYSIS WITH COMPLAINT OF SUCTION ISSUE. VISUAL INSPECTION WAS PERFORMED. AS RECEIVED, THE PROXIMAL END OF THE PILOT BALLOON-TUBING JUNCTION WAS SEEN TO BE KINKED. SUCTION LINE WAS FILLED WITH AIR AND A LEAK WAS OBSERVED COMING FROM A TEAR IN THE LINE BY THE TRACH FLANGE. THE COMPLAINT OF SUCTION DIFFICULTY WAS CONFIRMED. THE PROBABLE CAUSE IS DUE TO UNINTENTIONAL EXTERNAL BENDING FORCES ON THE SUCTION LINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUCTION WAS DIFFICULT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333581 PORTEX TUBES BLUSELECT TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL CZECH REPUBLIC A. S NI 15019517076226

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown