BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 24176561 · Received January 26, 2026

    Report

    Report Number
    9614033-2026-00005
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    December 9, 2025
    Report Date
    March 12, 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

    ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. BASED ON THE PHOTO ALONE, THE REPORTED LEAK DEFECT COULD NOT BE VERIFIED AS A LEAK WAS NOT VISIBLE IN THE PHOTO. 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.

    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 5ML LL BNS HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 304656; BATCH#: 4205643. IT WAS REPORTED BY THE CUSTOMER THAT DEFECTIVE SYRINGES - LEAKING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. XXX COMPLAINT #: (B)(4). DEFECT DESCRIPTION: DEFECTIVE SYRINGES - LEAKING. XXX PART #: 153245. PRODUCT DESCRIPTION: SYRINGE 5ML LL BNS. VENDOR PART #: 304656. LOT #: 4205643. DATE REPORTED: 12/8/2025. SAMPLE RECEIVED: NO. RESPONSE NEEDED: YES - INCIDENT REPORTED TO THE FDA AS MDR-30 DAY. REFERENCE NO. 1417592-2025-00759. ADDITIONAL INFO: THE END USER DID NOT NOTE ANYTHING UNUSUAL WITH THE SYRINGE. FURTHER INFORMATION REGARDING THE LEAK IS UNAVAILABLE, AS WE DID NOT GET A DETAILED RESPONSE FROM THE END USER. 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? 09-12-2025. 4. TOTAL NUMBER OF OCCURRENCES? 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574009 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 4205643

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown