BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX TUBES BLUSELECT SUCTIONAID

    MDR report key: 19359349 · Received May 21, 2024

    Report

    Report Number
    3012307300-2024-03981
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    April 1, 2024
    Report Date
    June 19, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    UDI-DI
    15019517076134
    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

    B3: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED; DAY IS UNKNOWN. H3: OTHER; DEVICE NOT RETURNED TO MANUFACTURER. 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

    H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. SIMILAR CUSTOMER COMPLAINTS HAVE BEEN RECENTLY RECEIVED AND 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 WHEN THE OPERATOR TRIED TO PUSH AIR IN THE PILOT BALLOON, THE PILOT BALLOON CAME OFF. THIS OCCURRED UPON OPENING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220322 PORTEX TUBES BLUSELECT SUCTIONAID TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD, INC. 101/860/070 NI 15019517076134

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown