BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 23751962 · Received December 8, 2025

    Report

    Report Number
    9614033-2025-00122
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 18, 2025
    Report Date
    March 23, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTOR DISPOSED OF PHYSICAL SAMPLE. WE COULD NOT PERFORM A SAMPLE ANALYSIS. THREE PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. BASED ON THE PHOTOS ALONE, THE REPORTED LEAKAGE WAS NOT OBSERVED; THEREFORE, THE REPORTED INCIDENT COULD NOT 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, A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. ADDRESS WAS NOT LOCATED AND (B)(6) 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

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 304657, BATCH#: 5020038. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. MEDLINE COMPLAINT #: (B)(4). DEFECT DESCRIPTION: CUSTOMER REPORT: ¿10ML SYRINGES ARE LEAKING.¿ XXXXXKIT #: PAIN1062B, XXXXPART #: 153239. PRODUCT DESCRIPTION: SYRINGE 10ML LL BNS. VENDOR PART #: 304657. LOT #: 5020038. DATE REPORTED: 11/05/2025. SAMPLE RECEIVED: YES. WE EVALUATED THREE RETURNED SYRINGES, AND WE DID NOT CONFIRM THE REPORTED ISSUE. RESPONSE NEEDED: COMPLETION OF THE ATTACHED SOP31 FORM WITHIN 15 DAYS OF RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202441 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 5020038 00382903046577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown