BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 23011826 · Received September 9, 2025

    Report

    Report Number
    9614033-2025-00091
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 25, 2025
    Report Date
    December 5, 2025
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. 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. RETENTION SAMPLES ARE NOT ANALYZED BECAUSE THE CUAUTITLAN PLANT DOES NOT STERILIZE THE PRODUCT, ONLY MANUFACTURES IT. HOWEVER, OPERATING STAFF WILL BE NOTIFIED OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS HAD VISIBLE DROPLETS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 304657 BATCH # 4205658. RCC RECEIVED A COMPLAINT VIA EMAIL. MEDLINE COMPLAINT #: (B)(4), DEFECT DESCRIPTION: MOISTURE IN SYRINGE, MEDLINE PART #: 153239, PRODUCT DESCRIPTION: SYRINGE 10ML LL BNS, VENDOR PART #: 304657, LOT #: 4205658, DATE REPORTED: (B)(6) 2025, SAMPLE RECEIVED: NO. RESPONSE NEEDED: SUMMARY OF FINDINGS & CORRECTIVE ACTIONS -- INCIDENT REPORTED TO THE FDA AS MDR-30 DAY. REFERENCE NO. 3004122598-2025-00005.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2868722 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 4205658 00382903046577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown