BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 24206111 · Received January 28, 2026

    Report

    Report Number
    9614033-2026-00007
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    December 17, 2025
    Report Date
    February 23, 2026
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    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

    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: THE CLAIM IS CLASSIFIED AS UNCONFIRMED, SINCE THERE ARE NO PHYSICAL SAMPLES OR PHOTOGRAPHIC EVIDENCE TO VERIFY THE CONDITION OF THE SYRINGE. IT IS IMPORTANT TO MENTION THAT NO QUALITY EVENTS RELATED TO THE REPORTED DEFECT WERE FOUND IN THE BATCH RECORD DURING THE PRODUCT¿S MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS BARREL / FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 304657 BATCH#: 5020043. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. XXX COMPLAINT #: (B)(4), DEFECT DESCRIPTION: SYRINGE BROKE, PART #: 153239, PRODUCT DESCRIPTION: SYRINGE 10ML LL BNS, VENDOR PART #: 304657, LOT #: 5020043, DATE REPORTED: (B)(6) 2025. SAMPLE RECEIVED: NO RESPONSE NEEDED: YES - INCIDENT REPORTED TO THE FDA AS MDR-30 DAY. REFERENCE NO. 1423395-2026-00010. ADDITIONAL INFORMATION PROVIDED: 1. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? DURING USE 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO 3. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 17-12-2025 4. TOTAL NUMBER OF OCCURRENCES? 1 5. COULD YOU PROVIDE A MORE DETAILED ENTRY DESCRIPTION? NO 6. WHICH PART OF THE SYRINGE IS BROKEN? UNK ¿ CUSTOMER REPORTED ¿SYRINGE SHATTERED AND BODILY FLUID SPRAYED AROUND¿.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340380 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 5020043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown