BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP

    MDR report key: 23295690 · Received October 15, 2025

    Report

    Report Number
    9616066-2025-03094
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 18, 2025
    Report Date
    January 13, 2026
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403221705
    PMA / PMN Number
    K053049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THREE PHOTOS WERE RECEIVED FOR QUALITY EVALUATION. EXAMINATION OF THE PHOTOS SHOW THAT THERE IS LEAKAGE AT THE CONNECTION POINT BETWEEN THE TEXIUM CONNECTOR AND A BD SMARTSITE CONNECTION POINT. THE CUSTOMER COMPLAINT OF LEAKAGE WAS CONFIRMED. A TREND HAS BEEN IDENTIFIED, AND ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THE ISSUE. CORRECTIVE ACTIONS TAKEN DURING THIS INVESTIGATION WILL BE IMPLEMENTED IN OUR PRODUCTION PROCESS TO FURTHER INCREASE THE ROBUSTNESS AND RELIABILITY OF THE DEVICE AND PREVENT FUTURE OCCURRENCES OF THIS TYPE. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10012241-0500 LOT NUMBER 24095556 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) HAS EXPERIENCED SEVERAL TEXIUM LEAKS STANDALONE AND BONDED WHILE INFUSING CHEMO / HD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449643 BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A DE C.V. 24095556 10885403221705

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown