BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL BN

    MDR report key: 22958588 · Received September 3, 2025

    Report

    Report Number
    1213809-2025-00574
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 4, 2025
    Report Date
    October 6, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    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.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION ONE PHOTO AND ONE SAMPLE OF A 3 ML LUER-LOK SYRINGE (PART NUMBER 301073) WERE RECEIVED AND EVALUATED. THE SAMPLE ARRIVED FULLY ASSEMBLED AND WAS LOOSELY ATTACHED TO AN UNIDENTIFIED SHEET OF PAPER. UPON INSPECTION, A BROWN FOREIGN MASS WAS OBSERVED EMBEDDED WITHIN THE BARREL, SPECIFICALLY BETWEEN THE COLLAR AND THE ROOF. THE PHOTO PROVIDED WAS CONSISTENT WITH THE CONDITION OBSERVED IN THE PHYSICAL SAMPLE. THE PRESENCE OF THE FOREIGN MATERIAL IS CONSIDERED NON-CONFORMING PER PRODUCT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE OF THE EMBEDDED FOREIGN MATTER IS ASSOCIATED WITH THE MOLDING PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR THE PROVIDED LOT NUMBER 4031173, WHICH SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT THAT A SYRINGE IS CONTAMINATED THE SAMPLE HAS BEEN RETURNED, AND IT SEEMS TO BE A MARK IN THE SYRINGE, SEE IMAGE ATTACHED. I TRIED TO DISLODGE THE BLACK MARK, AND IT SEEMS TO IN THE PLASTIC OUR RECORD SHOWS A DISTRIBUTION OF THIS LOT FOR (B)(4)UNITS, NO OTHER REPORTS. OUR DATABASE OF COMPLAINTS SHOWS NO PREVIOUS ISSUE, AT LEAST IN THE LAST 3 YEARS. CONTAMINATED/ MARKED SYRINGE 6803/NS (YOUR CODE 301073, LOT 4031173

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473669 BD SYRINGE 3ML LL BN PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4031173

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown