BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUSELECT TRACHEOSTOMY TUBE

    MDR report key: 19726360 · Received July 11, 2024

    Report

    Report Number
    3011237704-2024-00141
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    May 22, 2024
    Report Date
    August 5, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    BTO
    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 INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE USED DECONTAMINATED 10009163-003 7.5MM DEHT BLU SUCTIONAID SUB-ASSY WAS RETURNED FOR INVESTIGATION. UNDER VISUAL INSPECTION IT WAS NOTICED THAT THE INFLATION LINE WAS DETACHED FROM THE PILOT BALLOON, AS WAS REPORTED BY CUSTOMER. THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THIS ISSUE WAS ESCALATED TO CAPA-000905. NO COMPLAINT SIGNAL IS CURRENTLY OBSERVED. A DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS NO LOT NUMBER WAS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PILOT BALLOON WAS REMOVED DURING USE. THE EVENT OCCURRED DURING PATIENT USE, AND NO PATIENT HARD/ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272087 PORTEX BLUSELECT TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown