BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 24188978 · Received January 27, 2026

    Report

    Report Number
    1911916-2026-00041
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 21, 2026
    Report Date
    February 10, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. A SYRINGE WAS REPORTED TO BE DIRTY. TO SUPPORT THE INVESTIGATION, ONE SAMPLE IN AN OPENED BLISTER PACKAGE AND THREE PHOTOGRAPHS WERE RECEIVED AND EVALUATED BY THE QUALITY TEAM. VISUAL INSPECTION OF THE RETURNED SYRINGE IDENTIFIED THREE EMBEDDED BROWN SPECKS AT THE BOTTOM OF THE BARREL, NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTOGRAPHS CORROBORATE THE CONDITION OF THE RETURNED SAMPLE. THE APPEARANCE IS CONSISTENT WITH EMBEDDED DEGRADED RESIN, WHICH CAN OCCUR AT STARTUP OR INTERMITTENTLY DURING INJECTION MOLDING WHEN SMALL FRAGMENTS BREAK LOOSE AND ARE INCORPORATED INTO MOLDED COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 309653, LOT 5142409. THE REVIEW IDENTIFIED NO QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMERS REPORTED CONDITION IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT IS REPORTED FOREIGN MATTER. DESCRIPTION: WHILE A PHARMACY TECHNICIAN WAS MAKING CHEMO THIS MORNING, SHE WENT TO USE THIS SYRINGE AND WHEN SHE PULLED IT OUT OF THE WRAPPER, SHE NOTICED THAT IT WAS DIRTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253231 LUER-LOK SYRINGE, PISTON FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5142409 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown