BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX ENDOTRACHEAL TUBE, SILICONIZED

    MDR report key: 22009409 · Received May 13, 2025

    Report

    Report Number
    3012307300-2025-05576
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 17, 2025
    Report Date
    July 1, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    BTR
    UDI-DI
    15019315054105
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED: G1 - CONTACT OFFICE ESTABLISHMENT NAME. ONE (1) USED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND THE REPORTED ISSUE COULD NOT BE DUPLICATED. NO LEAKS WERE OBSERVED FROM THE CUFF. THE CUFF INFLATED SUCCESSFULLY. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

    Additional Manufacturer Narrative · 0

    H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. H4. DEVICE MFG DATE: THE REPORTED LOT# 6010558 WAS NOT FOUND FOR THE REPORTED CATALOG# 100/166/080 IN THE SYSTEM; THEREFORE, THE MANUFACTURING DATE COULD NOT BE CONFIRMED. 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 THERE WAS AN AIR LEAK 48 HOURS AFTER INTUBATION. THE INTUBATION TUBE WAS REPLACED AND UPON CHECKING THERE WAS A PIN HOLE ON THE TOP OF THE CUFF. THE EVENT OCCURRED WHILE PATIENT USE AT THE FACILITY. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369920 PORTEX ENDOTRACHEAL TUBE, SILICONIZED TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6010558 15019315054105

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown