BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUSELECT PLAIN INNER CANNULA

    MDR report key: 20833251 · Received December 3, 2024

    Report

    Report Number
    9617604-2024-00905
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 1, 2024
    Report Date
    May 2, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    BTO
    UDI-DI
    15019517077834
    PMA / PMN Number
    K173384
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D9 - DATE RETURNED TO MFG: 13-MAR-2025. H3: TWO HUNDRED AND FIFTY SAMPLES WERE RETURNED FOR ANALYSIS. THE RETURNED SAMPLES WERE VISUALLY INSPECTED, AND NO DAMAGE OR OTHER VISUAL DEFECTS WERE DETECTED IN ALL THE RETURNED SAMPLES. ALL THE FIFTY-NINE SAMPLES THAT WERE TESTED PASSED. THE REPORTED ISSUE WAS NOT CONFIRMED. AND THE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. H4. DEVICE MFG DATE: THE REPORTED LOT# 4466322 COULD NOT BE FOUND FOR THE REPORTED CATALOG# 101/858/060; THEREFORE, THE MANUFACTURING DATE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SIZE 8 INNER CANNULA WAS NOT LOCKING INTO PLACE. THIS IS A CONTINUATION OF AN ONGOING INVESTIGATION. THE ROOT CAUSE OF THE ISSUES REPORTED WITH THE PREVIOUS LOT NUMBER HAS BEEN IDENTIFIED. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT IN THE HOSPITAL. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THE TUBE WAS REPLACED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292404 PORTEX BLUSELECT PLAIN INNER CANNULA TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4466322 15019517077834

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention