BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUSELECT PLAIN INNER CANNULA TRACH TUBE 50 PK

    MDR report key: 20200758 · Received September 12, 2024

    Report

    Report Number
    9617604-2024-00708
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 7, 2024
    Report Date
    November 13, 2024
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    BTO
    UDI-DI
    15019517077865
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. PRIMARY UDI NUMBER: THE PRIMARY DI# HAS BEEN USED AS THE LOT/SERIAL INFORMATION IS UNKNOWN. H4. DEVICE MFG DATE: THE REPORTED LOT# 4443599 COULD NOT BE FOUND FOR THE REPORTED CATALOG# 101/858/080; 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.

    Additional Manufacturer Narrative · 0

    NO DEVICE OR DEVICE PHOTO WAS RETURNED FOR INVESTIGATION. FUNCTIONAL AND VISUAL TESTING COULD NOT BE PERFORMED AND NO CONFIRMATION DUE TO NO DEVICE RETURNED. DUE TO THIS, NO ROOT CAUSE WAS DETERMINED. 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 SIZE 8.0 INNER CANNULAS WERE REPORTEDLY FALLING OUT AND NOT CLICKING INTO SIZE 8.0 TRACH. THE EVENT OCCURRED DURING QUALITY CONTROL TESTING AT SUPPLY ROOM ON UNUSED EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515145 PORTEX BLUSELECT PLAIN INNER CANNULA TRACH TUBE 50 PK TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4443599 15019517077865

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown