BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 24392702 · Received February 19, 2026

    Report

    Report Number
    1213809-2026-00079
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    February 3, 2026
    Report Date
    March 25, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 1ML LL CONTAINED FOREIGN MATTER. VERBATIM: A CLINICAL TRIAL SITE HAS NOTED THAT THERE ARE BLACK BLEMISHES/SPOTS VISIBLE ON OR IN BD SYRINGES. PLEASE SEE ATTACHED PICTURE EVIDENCE. CONFIRMED PRODUCTS AND LOT NUMBERS SO FAR THAT ARE CONFIRMED ARE BELOW: BD 1ML SYRINGES LOT: 4354445 EXPIRY: 2029-11-30. BD 3ML SYRINGES LOT: 4352796 EXPIRY: 2029-11-30. BD 3ML SYRINGES LOT: 5072741 EXPIRY: 2030-02-28. AS WE HAVE CHECKED OUR INVENTORY, WE HAVE ALSO FOUND EXTRA LOTS WITH THE SAME DEFECT, WE ARE CONTINUING OUR CHECKS INTERNALLY. HOWEVER, AS WE HAVE STOCK TO SAMPLE WOULD BE COLLECTED FROM US RATHER THAN OUR CLIENT SITES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455986 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5101152 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other