BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TEXIUM NEEDLE-FREE SYRINGE

    MDR report key: 23459095 · Received November 3, 2025

    Report

    Report Number
    9616066-2025-03355
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    September 29, 2025
    Report Date
    December 23, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403221699
    PMA / PMN Number
    K071108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE OF SYRINGE MY8060 WAS RECEIVED FOR QUALITY EVALUATION. THE SAMPLE WAS CONNECTED TO A SAMPLE BD SMARTSITE AND A FLUID DRAW AND PUSH WAS CONDUCTED TO DETERMINE IF THERE WAS LEAKAGE BETWEEN THE TEXIUM AND SMARTSITE. THERE WAS LEAKAGE IDENTIFIED COMING FROM BETWEEN THE TEXIUM AND THE BD SMARTSITE. 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 MY8060 LOT NUMBER 25017237 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD TEXIUM NEEDLE-FREE SYRINGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD 50ML TEXIUM SYRINGE MY8060 BROKE OFF AT BOND, RESULTING IN APPROX. 50ML FLUOROURACIL LOSS. LOT: 25017237 EXP: 01-21-2028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480402 BD TEXIUM NEEDLE-FREE SYRINGE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A DE C.V. 25017237 10885403221699

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown