BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL 200 S/C

    MDR report key: 23788409 · Received December 12, 2025

    Report

    Report Number
    1213809-2025-00767
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 30, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP. AS NO PHYSICAL OR PICTURE SAMPLE, OR VALID LOT NUMBER WAS PROVIDED FOR EVALUATION, BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE.

    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 THE BD SYRINGE 3ML LL 200 S/C HAD LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DRAWING UP MEDICATION INTO THE SYRINGE, THE PLUNGER STOPPER FAILED AND THE MEDICATION LEAKED OUT DOWN THE PLUNGER AND ONTO THE BENCH. INSPECTION OF FOLLOWING SYRINGES USED TO CHECK FOR DAMAGE TO PLUNGER STOPPERS ADDITIONAL INFORMATION PROVIDED: 3ML LUER-LOK SYRINGE: WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN NO PATIENT OR USER WAS HARMED COULD YOU PLEASE PROVIDE THE CATALOGUE NUMBER OF THE DEFECTIVE PRODUCT? COULD YOU PLEASE PROVIDE THE LOT NUMBER OF THE DEFECTIVE PRODUCT? BN: 5237662 EXP: 30/07/2030. WHAT MEDICATION WAS USED WHEN LEAKAGE OCCURRED? POVIDONE IODINE MINIMS WERE BEING DRAWN UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2695467 BD SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5237662 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown