BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 23360205 · Received October 22, 2025

    Report

    Report Number
    9614033-2025-00106
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    August 14, 2025
    Report Date
    October 9, 2025
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 304657. BATCH#: UNKNOWN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COMPLAINT NUMBER(S): (B)(4) PRODUCT SKU: COMPONENT 153239 (SYRINGE 10ML LL BNS) PRODUCT LOT NUMBER: 304657 COMPLAINT DETAILS: ¿CUSTOMER STATED THAT THEY EPIDURAL TRAY HAS BEEN IDENTIFIED AS HAVING A DEFECTIVE LEUR LOCK CONNECTION. THE CUSTOMER STATES ITS SPECIFIC TO THIS LOT NUMBER AS THEIR TEAM HAS TRIED VARIOUS OTHER TRAYS AND THE SYRINGE WORKED FINE. CUSTOMER STATED THAT LOT 25EBG990 LEAKS MEDICATION THROUGH THE 10ML SYRINGE PROVIDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611671 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown