BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 24048628 · Received January 12, 2026

    Report

    Report Number
    9614033-2025-00131
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 24, 2025
    Report Date
    February 12, 2026
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903046577
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE PHOTO SHOWS THAT THE STOPPER PRESENTS A DEFORMATION; THEREFORE, THE REPORTED INCIDENT COULD BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE FOR THIS INCIDENT CAN BE TRACED TO MANUFACTURING. THIS DEFECT CAN BE GENERATED DURING THE CYLINDER PLUNGER STOPPER ASSEMBLY STAGE. ACTIONS HAVE BEEN PUT IN PLACE DUE TO THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS STOPPER WAS DEFECTIVE / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 304657 BATCH # 4233722 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CUSTOMER REPORT: ¿IN THE 10ML SYRINGE, THE BLACK RUBBER PIECE WAS DETERIORATED AND CAUSED SOME LEAKING.¿ VENDOR PART #: 304657 LOT #: 4233722.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109597 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 4233722 00382903046577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown