BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX MAXILLOFACIAL ENDOTRACHEAL TUBE W/ CUFF

    MDR report key: 21333077 · Received February 7, 2025

    Report

    Report Number
    9617604-2025-00106
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    October 1, 2024
    Report Date
    February 7, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    BTR
    UDI-DI
    15019315020353
    PMA / PMN Number
    K931735
    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. DATE OF EVENT: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, BUT DAY IS UNKNOWN. H4. DEVICE MFG DATE: THE REPORTED LOT# 4318448 COULD NOT BE FOUND FOR THE REPORTED CATALOG# 100/133/070; THEREFORE, THE MANUFACTURING DATE COULD NOT BE DETERMINED. INVESTIGATION SUMMARY: FIVE PHOTOS WERE RECEIVED FOR EVALUATION. PER PHOTOS RECEIVED, HOLE WAS OBSERVED NEAR OF INFLATION LINE ASSEMBLED. ONE SAMPLE WAS RECEIVED IN UNUSED CONDITION FROM PART NUMBER 100/133/070 WITHIN ORIGINAL PACKAGE. THE SAMPLE WAS INSPECTED UNDER NORMAL CONDITIONS OF ILLUMINATION AT 12¿ OF DISTANCE. HOLE WAS DETECTED NEAR THE ASSEMBLED INFLATION. BREAKAGE/CUT FAILURE MODE WAS CONFIRMED. ROOT CAUSE ANALYSIS WILL BE CONDUCTED THROUGH RUN RATE TRENDING. CUSTOMER COMPLAINT NOTIFICATION WAS CONDUCTED TO OPERATIONS PERSONNEL AS AWARE OF THE REPORTED FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE TUBE WAS CHECKED, A HOLE WAS FOUND IN THE TUBE BODY NEAR THE CONNECTION OF THE INFLATION LINE. THE EVENT OCCURRED DURING TESTING AT THE FACILITY, NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298015 PORTEX MAXILLOFACIAL ENDOTRACHEAL TUBE W/ CUFF TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4318448 15019315020353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown