BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BN

    MDR report key: 23607164 · Received November 20, 2025

    Report

    Report Number
    9614033-2025-00114
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    September 23, 2025
    Report Date
    February 5, 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
    003

    Narratives

    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. OPERATING STAFF WILL BE NOTIFIED OF THIS EVENT.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS STOPPER WAS DAMAGED / DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #304657, BATCH #4340308. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT #: (B)(4), DEFECT DESCRIPTION: SYRINGE ISSUE- CONTENTS EJECTING, MEDLINE PART #: 153239, PRODUCT DESCRIPTION: SYRINGE 10ML LL BNS, VENDOR PART #: 304657, LOT #: 4340308, DATE REPORTED: 9/29/2025, SAMPLE RECEIVED: NO, RESPONSE NEEDED: SUMMARY OF FINDINGS & CORRECTIVE ACTIONS -- INCIDENT REPORTED TO THE FDA AS MDR-30 DAY. ADDITIONAL INFORMATION PROVIDED: 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? SYRINGE MALFUNCTION LED TO CONTENTS EJECTING, 2. WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? UNK, 3. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE ON PATIENT? DURING USE, 4. WHAT WAS THE IMPACT TO THE PATIENT? NO IMPACT, 5. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN MM-DD-YYYY FORMAT? (B)(6)2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315165 BD SYRINGE 10ML LL BN PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 4340308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown