BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY

    MDR report key: 19306309 · Received May 13, 2024

    Report

    Report Number
    3011237704-2024-00102
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 1, 2024
    Report Date
    June 18, 2024
    Manufacturer
    SMITHS MEDICAL CZECH REPUBLIC A. S
    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

    MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED; DAY IS UNKNOWN. 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: ONE USED DECONTAMINATED SAMPLE WAS RETURNED FOR INVESTIGATION. UNDER VISUAL INSPECTION WE NOTICED THAT INFLATION LINE WAS DETACHED FROM PILOT BALLOON AS REPORTED BY CUSTOMER. THIS ISSUE WAS ESCALATED TO CAPA-000905. 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 CAME OFF DURING PATIENT USE. THERE WAS A PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521846 PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL CZECH REPUBLIC A. S 101/860/075 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown