BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX GENERAL ANESTHESIA CIRCUITS

    MDR report key: 22328272 · Received June 25, 2025

    Report

    Report Number
    3012307300-2025-07633
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    June 1, 2025
    Report Date
    June 25, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    CAI
    UDI-DI
    15019315075834
    PMA / PMN Number
    NOT RELEASED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE DEVICE HISTORY RECORD OF REPORTED LOT 6051712 WAS REVIEWED, AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. WITHOUT THE RETURN OF THE USED SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE WAS CONFIRMED FROM THE LEAKAGE, SO USAGE OF THE PRODUCT WAS CEASED. PER REPORTER, THE ISSUE WAS DISCOVERED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328369 PORTEX GENERAL ANESTHESIA CIRCUITS CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6051712 15019315075834

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown