BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX AIRWAY NASOPHARYNGEAL INTUBATION SYSTEM

    MDR report key: 18270761 · Received December 5, 2023

    Report

    Report Number
    3012307300-2023-10911
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    October 1, 2023
    Report Date
    February 14, 2024
    Manufacturer
    ST PAUL
    Product Code
    BTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EMAIL IS: (B)(6). H3 AND H6 - EVALUATION CODES: UPDATED. DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION FOUND A CONTAMINATION OF FOREIGN MATTER WAS OBSERVED INSIDE THE POUCH, SIZE 0.40 MM SQUARED. THE COMPLAINT WAS CONFIRMED. 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. ROOT CAUSE OF THE ISSUE WAS ATTRIBUTED TO MANUFACTURING. IT WAS OBSERVED SOME LOOSE PLASTIC PARTICLES RESIDUES OCCUR AFTER THE MULTIVAC CUT THE TYVEK. THIS LIGHTLY LOOKS LIKE THE FOREIGN MATERIAL OBSERVED IN THE COMPLAINT. THESE PARTICLES ARE FOUND AFTER SEALING OF THE PACKAGING, THEY MAY BE A POTENTIAL SOURCE OF THE REPORTED COMPLAINT. AWARENESS FOR FAILURE MODE CONTAMINATION INSIDE PACKAGE WAS GIVEN TO PERSONNEL WHO PERFORM THE ASSEMBLY PROCESS OF CODE.

    Additional Manufacturer Narrative · 0

    OTHER TEXT: B3: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, DAY IS UNKNOWN. D4: UDI SECTION IS UNKNOWN. G5: 510K IS BLANK, BTQ PRODUCT CODE IS 510K EXEMPT. D3, G1, AND G2 EMAIL IS: (B)(6). 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 UPON OPENING, THE DEVICE WAS FOUND TO HAVE CONTAMINATION WITH FOREIGN MATTER. NO ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2232165 PORTEX AIRWAY NASOPHARYNGEAL INTUBATION SYSTEM AIRWAY, NASOPHARYNGEAL BTQ ST PAUL 4334578

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown