BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 22650470 · Received July 29, 2025

    Report

    Report Number
    1213809-2025-00500
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    June 20, 2025
    Report Date
    September 19, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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) FOLLOW UP FOR DEVICE EVALUATION. ONE PHOTO AND ONE SAMPLE OF A 10 ML LUER-LOK SYRINGE (PART NUMBER 301029) WERE RECEIVED AND EVALUATED. THE SAMPLE, RECEIVED FULLY ASSEMBLED AND LOOSE, EXHIBITED AN UNKNOWN BROWN FOREIGN MATERIAL INSIDE THE FLUID PATH. THE PHOTO PROVIDED WAS CONSISTENT WITH THE CONDITION OBSERVED DURING SAMPLE EVALUATION. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATERIAL IN FLUID PATH DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 4352162, 5010440, 5016831, 5016834, 5035833 AND 5041302. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    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: MATERIAL #301029 LOT #UNKNOWN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ITEM : 301029. LOT NUMBER: COULD NOT BE DETERMINED. ISSUE: A LARGE BROWN UNIDENTIFIED PARTICLE WAS FOUND IN ONE SYRINGE. PHOTO ATTACHED: YES- 1. SAMPLES AVAILABLE : YES - 1. THE FOLLOWING LOT NUMBERS WERE USED: ¿ 4352162 QTY. (B)(4). ¿ 5010440 QTY. (B)(4). ¿ 5016831 QTY. (B)(4). ¿ 5016834 QTY. (B)(4). ¿ 5035833 QTY. (B)(4). ¿ 5041302 QTY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861470 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown