BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 23676901 · Received November 29, 2025

    Report

    Report Number
    9614033-2025-00118
    Event Type
    Malfunction
    Date Received
    November 29, 2025
    Date of Event
    November 11, 2025
    Report Date
    March 24, 2026
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903046560
    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

    INVESTIGATION RESULTS: ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. IN THE PHOTO, A SYRINGE CONTAINS A WHITE LIQUID WITH A BLACK-COLORED PARTICLE; THEREFORE, FOREIGN MATTER IN THE SYRINGE CAN BE VERIFIED. ALTHOUGH THE PHOTO SHOWS WHAT COULD BE A PARTICLE OR FOREIGN MATTER, THE ABSENCE OF THE PHYSICAL SAMPLE MAKES IT IMPOSSIBLE PERFORM IDENTIFICATION ANALYSES TO DETERMINE THE ORIGIN OR NATURE OF THE MATERIAL. 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, A ROOT CAUSE COULD NOT BE DETERMINED WITHOUT A PHYSICAL SAMPLE. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    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: MATERIAL#: 304656 BATCH#: 4205617 IT WAS REPORTED BY THE CUSTOMER THAT BLACK FOREIGN OBJECT IN SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. MEDLINE COMPLAINT #:(B)(4). DEFECT DESCRIPTION: CUSTOMER REPORT: ¿BLACK FOREIGN OBJECT IN SYRINGE.¿ XXXX KIT #: DYNJRA1665B XXXXXX PART #: 153245 PRODUCT DESCRIPTION: SYRINGE 5ML LL BNS VENDOR PART #: 304656 LOT #: 4205617 DATE REPORTED: 10/28/2025 SAMPLE RECEIVED: NO RESPONSE NEEDED: COMPLETION OF THE ATTACHED SOP31 FORM WITHIN 15 DAYS OF RECEIPT 304656 4205617 ADDITIONAL INFORMATION PROVIDED: "I WANT TO CLARIFY THAT THE PARTICULATE ISN¿T COMING FROM THE MEDICATION¿THEY NO LONGER ENCOUNTERED ISSUES WHEN THEY USED A DIFFERENT SYRINGE THAT WASN¿T SUPPLIED IN THE KIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51834 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 4205617 00382903046560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown