BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 23811695 · Received December 15, 2025

    Report

    Report Number
    1213809-2025-00779
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    December 2, 2025
    Report Date
    February 10, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903010295
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER. ONE SAMPLE AND ONE PHOTO OF A 10 ML LUER LOK SYRINGE (PART NUMBER 301029) WERE RECEIVED AND EVALUATED. THE PHOTO SHOWS A FULLY ASSEMBLED, LOOSE SYRINGE FILLED WITH AN UNIDENTIFIED TRANSPARENT FLUID CONTAINING A YELLOW BROWNISH FOREIGN MATERIAL WITHIN THE FLUID PATH, AND THE PHYSICAL SAMPLE MATCHED THIS CONDITION. BASED ON THE AVAILABLE EVIDENCE, THE OBSERVED CONDITION IS NON CONFORMING TO PRODUCT SPECIFICATIONS, AND THE POTENTIAL ROOT CAUSE OF THE FOREIGN MATERIAL IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW FOR MATERIAL 301029 ACROSS ALL REPORTED LOTS (5099832, 5120095, 5121749, 5121753, 5144338, 5148026, AND 5157908) CONFIRMED THAT ALL IN PROCESS AND FINAL VISUAL INSPECTIONS WERE COMPLETED AS REQUIRED, WITH NO QUALITY NOTIFICATIONS RELATED TO THIS CONDITION. ALL LOTS MET ACCEPTANCE CRITERIA PER THE INSPECTION CONTROL PLAN, WERE APPROVED FOR SHIPMENT, AND COMPLIED WITH APPLICABLE PRODUCT SPECIFICATIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED THROUGH MONTHLY REPORTS, WHICH ARE REGULARLY REVIEWED BY OUR BUSINESS TEAM TO IDENTIFY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTED. MATERIAL#: 301029, BATCH#: UNKNOWN. POTENTIAL LOT: (5099832,5120095,5121749,5121753,5144338,5148026,5157908). RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT INFORMATION. BD PART NUMBER: 301029, PART NUMBER DESCRIPTION: 10ML LUER LOCK SYRINGE (BULK, NON-STERILE). DESCRIPTION OF DISCREPANCIES: MPS'S CUSTOMER FILED A COMPLAINT ON (B)(6) 2025 REGARDING A LARGE UNIDENTIFIED BROW PARTICLE IN THE BARREL OF A SYRINGE. THE CUSTOMER PROVIDED ATTACHED FIGURES DEMONSTRATING THE DEFECT FOR REFERENCE. IT IS IMPORTANT TO NOTE THAT THE AFFECTED LOT NUMBER COULD NOT BE IDENTIFIED, AS THE SYRINGES IN QUESTION WERE PART OF A JOB MANUFACTURED WITH SYRINGES FROM SEVEN DIFFERENT LOTS. FOR TRACEABILITY PURPOSES, THE FOLLOWING LOT NUMBERS WERE USED IN THE MANUFACTURING OF THAT JOB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789994 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 00382903010295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown