BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 22502698 · Received July 14, 2025

    Report

    Report Number
    1213809-2025-00472
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    June 26, 2025
    Report Date
    September 4, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Additional Manufacturer Narrative · 0

    (B)(4) SUPPLEMENTAL MDR - FOREIGN MATTER. THREE PHOTOS AND ONE LOOSE SAMPLE OF A 10ML LUER-LOK SYRINGE (PART NUMBER 301029) WERE RECEIVED FOR EVALUATION. THE LOOSE SYRINGE SAMPLE EXHIBITED UNKNOWN BLACK PARTICULATES ON THE PLUNGER ROD IN THE NON-FLUID PATH. ONE OF THE SUBMITTED PHOTOS SHOWED A LOOSE SYRINGE WITHOUT ANY VISIBLE DEFECTS, WHILE THE REMAINING TWO IMAGES WERE IDENTICAL CLOSE-UPS OF THE PLUNGER ROD AREA, CLEARLY HIGHLIGHTING THE BLACK PARTICULATES, WITH ONE IMAGE INCLUDING RED CIRCLES TO EMPHASIZE THE AFFECTED REGIONS. THESE FINDINGS CONFIRM THE PRESENCE OF PARTICULATE CONTAMINATION ON THE NON-FLUID PATH OF THE SYRINGE PLUNGER ROD. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER NON-FLUID PATH DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 5011351. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION 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 THE BD SYRINGE 10ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN OUR PRODUCTION, THE FOLLOWING WASTE WAS DETECTED DURING PROCESSING: ARTICLE: 301029, DESCRIPTION: BD PLASTIPAK 3-PART SYRINGE, 10 ML, BD LUER-LOK, DELIVERY NOTE: TOG/875186, BATCH: 5011351, AFFECTED QUANTITY: 1 PIECE, ERROR PATTERN: HEAVY SOILING INSIDE. HOW DID THIS ERROR PATTERN ARISE AND HOW CAN IT BE PREVENTED IN THE FUTURE?

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127863 BD SYRINGE 10ML LL BNS PISTON SYRI NGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5011351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown