BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 23067128 · Received September 16, 2025

    Report

    Report Number
    1213809-2025-00603
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 13, 2025
    Report Date
    November 10, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010276
    PMA / PMN Number
    K980987
    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 FOR DEVICE EVALUATION A TOTAL OF FOUR HUNDRED EIGHTY-NINE LOOSE SAMPLES AND FIVE PHOTOS OF 5 ML LUER-LOK SYRINGES (PART NUMBER 301027) WERE EVALUATED, REVEALING ONE HUNDRED TWENTY-NINE SAMPLES WITH ACCEPTABLE INK DOTS AND THREE HUNDRED SIXTY WITH GROSS INK RINGS AROUND THE BARREL, WHICH IS A NON-CONFORMING CONDITION PER PRODUCT SPECIFICATIONS. PHOTOS CONFIRMED THESE FINDINGS, SHOWING LOOSE SYRINGES WITH VISIBLE INK RINGS AND DOTS. A REVIEW OF TECHNICAL AND ELECTRICAL RECORDS AND THE PRODUCTION DATABASE IDENTIFIED NO RELATED ISSUES. THE POTENTIAL ROOT CAUSE IS ASSOCIATED WITH THE MARKING PROCESS, AND CORRECTIVE ACTIONS INCLUDE ESCALATING THE DEFECT TO ALL MANUFACTURING SUPERVISORS AND ISSUING A QUALITY ALERT TO THE PLANT. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 5021461. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP REPORT FOR CORRECTION. DATE RECEIVED BY MANUFACTURER WAS INCORRECT IN THE INITIAL MDR, DATE SHOULD BE 08/13/2025.

    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

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HOPE YOU'RE WELL. I¿D LIKE TO INFORM YOU THAT ON 13/08/2025, DURING PRODUCTION, WE IDENTIFIED DEFECTS IN SYRINGES 301027, LOT: 5021461 ¿ INK WAS SMUDGED OVER THE SYRINGE (PLEASE SEE BELOW AND ATTACHED PICTURES FOR YOUR REFERENCE). COULD YOU KINDLY FORWARD THIS TO THE APPLICABLE TEAM? THE OPERATORS CHECKED THE BAG FROM WHICH THESE SYRINGES WERE ISSUED TO THE LINE AND FOUND 468 UNITS WITH THE SAME ISSUE. THESE UNITS HAVE BEEN SEGREGATED AND ISOLATED FOR INVESTIGATION. A NEW BAG FROM THE SAME BATCH: (5021461) WAS OPENED, AND NO FURTHER DEFECTS WERE FOUND, HOWEVER, WE WILL REMAIN VIGILANT IN CASE ADDITIONAL DEFECTIVE SYRINGES SURFACE. AN INTERNAL NC REPORT HAS BEEN RAISED - REF. #: (B)(4). WE'D APPRECIATE IT IF YOU COULD CONFIRM RECEIPT OF THIS NOTIFICATION, INITIATE YOUR OWN INVESTIGATION, AND PROVIDE A ROOT CAUSE ANALYSIS AND CORRECTIONS/ CORRECTIVE ACTIONS. PLEASE ALSO ADVISE IF YOU WOULD LIKE US TO SEND 5 OR 10 SAMPLES FOR YOUR ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269020 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5021461 50382903010276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown