BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 25243469 · Received May 21, 2026

    Report

    Report Number
    1213809-2026-00263
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 13, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 5ML LL SP125 CONTAINED FOREIGN MATTER. COMPLAINT VIA EMAIL. MULTIPLE UNITS FROM THE SAME LOT FOR EACH OF THE ABOVE MATERIALS WERE ASSESSED AND PARTICLES WERE IDENTIFIED IN EACH OF INSPECTED UNITS AS DETAILED BELOW: 1. PART# 14-829-45/309646; LOT# 5112794 - 2 UNITS WITH PARTICLES FOUND (AS DESCRIBED BELOW): BLACK PARTICULATES, LOOSE, GETS STUCK EASILY, SMALL ROUND. WHITE PARTICULATE, LOOSE. PLEASE CONFIRM WHETHER THE ISSUES DESCRIBED AS ¿GETS STUCK EASILY,¿ ¿LOOSE,¿ AND ¿SMALL ROUND¿ PERTAIN TO FOREIGN MATTER, OR IF THEY INDICATE A DIFFERENT CONCERN, SUCH AS DIFFICULT PLUNGER MOVEMENT OR A SMALL SYRINGE SIZE. THESE DESCRIBE THE NATURE OF THE FOREIGN MATTER IN EACH OF THE CASES. KINDLY EXPLAIN WHAT IS MEAN BY IRREGULAR ISSUE. - INDICATES THAT THIS IS NON-UNIFORM AND ASYMMETRIC. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY WHERE THE SAMPLE IS AVAILABLE SO WE CAN SEND THE RETURN SHIPPING LABEL. YES, THE UNITS FROM EACH LOT WITH IDENTIFIED PARTICLES HAVE BEEN BLOCKED AND ARE STORED IN THE REJECT CAGE FOR RETURN TO THE SUPPLIER/MANUFACTURER FOR FURTHER INVESTIGATION, AS LISTED BELOW: SUPPLIER LOT# 5112794: 10 EA BLOCKED FOR RETURN, SUPPLIER LOT# 5183158: 36 EA BLOCKED FOR RETURN, SUPPLIER LOT# 4261489: 15 EA BLOCKED FOR RETURN, SUPPLIER LOT# 5212984: 32 EA BLOCKED FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133958 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5112794 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1