BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 24249034 · Received February 3, 2026

    Report

    Report Number
    1213809-2026-00047
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    August 26, 2025
    Report Date
    March 13, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    JKA
    UDI-DI
    50382903010290
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THAT A PARTICLE WAS TRAPPED BETWEEN THE INNER WALL OF THE SYRINGE BARREL. TO SUPPORT THE INVESTIGATION, OUR QUALITY TEAM RECEIVED A FOUR IMAGE PHOTO COLLAGE RELATED TO A 10 ML LUER LOCK SYRINGE. THREE IMAGES DEPICT A WOOD LIKE FOREIGN PARTICULATE WITHIN THE FLUID PATH, RESTING ON THE PLUNGER STOPPER. THE FOURTH IMAGE SHOWS THE UPPER SECTION OF A FULLY ASSEMBLED, LOOSE SYRINGE, HIGHLIGHTING THE AREA WHERE THE CUSTOMER REPORTED OBSERVING THE PARTICULATE. THE OBSERVED CONDITION IS NONCONFORMING TO PRODUCT SPECIFICATIONS AND IS ATTRIBUTABLE TO THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 301029 AND POSSIBLE LOT NUMBERS 4124548, 4173201, AND 4178276. THE REVIEW CONFIRMED THAT ALL VISUAL INSPECTIONS WERE PERFORMED AS REQUIRED, WITH NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION. THE LOTS WERE INSPECTED AND ACCEPTED PER THE INSPECTION CONTROL PLAN, APPROVED FOR SHIPMENT, AND DETERMINED TO BE IN COMPLIANCE WITH PRODUCT SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION, INCLUDING ANALYSIS OF THE PHOTOGRAPHIC EVIDENCE, THE CUSTOMER REPORTED CONDITION IS CONFIRMED.

    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 10ML LL BNS CONTAINED FOREIGN MATTER. VERBATIM: IT WAS REPORTED THAT PARTICLE WAS TRAPPED BETWEEN INNER WALL OF SYRINGE. WHEN DID THE INCIDENT OCCUR: BEFORE USE BROWN PARTICLE ADHERED TO THE SURFACE OF THE (CAPPED) SYRINGE PLUNGER AS PER THE PHOTOGRAPHS BELOW. THIS WAS BEFORE SYRINGE WAS USED TO DRAW UP ANY LIQUID. EXTERNAL LABORATORY PROVIDED THE FOLLOWING ASSESSMENT: ¿PARTICLE WAS TRAPPED BETWEEN INNER WALL [OF SYRINGE] AND SURFACE OF PLUNGER, SMALL FRAGMENT OF LIGHT BROWN COLOURED WOODY CELLULOSIC MATERIAL.¿ LOCATION OF PARTICLE MAKES IT HIGHLY UNLIKELY THAT IT ENTERED VIA THE SYRINGE NOZZLE (LUER). SUSPECTED TO HAVE ORIGINATED DURING SYRINGE MANUFACTURE MATERIAL # BD301029. LOT # ONE OF 4124548, 4173201, 4178276.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443805 BD SYRINGE 10ML LL BNS BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 50382903010290

    Patients

    Seq Age Sex Outcome Treatment
    1