BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 24248514 · Received February 3, 2026

    Report

    Report Number
    9614033-2026-00008
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    January 16, 2026
    Report Date
    February 25, 2026
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    N/A
    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. E.1. ADDRESS WAS NOT LOCATED, AND (B)(6) WAS USED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SEVEN PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. IN ONE OF THE PHOTOGRAPHS, AN IRREGULAR SCALE MARKING LINE CAN BE OBSERVED ON THE SYRINGE; HOWEVER, THE OBSERVED LINE DOES NOT REPRESENT A DEFECT THAT COULD AFFECT THE FUNCTIONALITY OF THE SYRINGE, NOR IS THERE ANY INDICATION OF THE SCALE MARKING FADING. ADDITIONALLY, ALTHOUGH SOME BLACK DOTS ARE VISIBLE ON THE SYRINGE AND THE TRAY IN THE PHOTOGRAPHS, IT IS NOT POSSIBLE TO DETERMINE WHETHER THEY CORRESPOND TO EMBEDDED PARTICLES, REMOVABLE RESIDUES, OR INK STAINS. THIS IS BECAUSE THE PHYSICAL SAMPLE IS NOT AVAILABLE TO PERFORM IR ANALYSIS OR OTHER VERIFICATION METHODS THAT WOULD ALLOW US TO DETERMINE THEIR ORIGIN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 5ML LL BNS CONTAINED FOREIGN MATTER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COMPLAINT #: (B)(4). DEFECT DESCRIPTION: PARTICULATE IN KIT. KIT #: PAIN1196A. PART #: 153239, 26001, 153245. PRODUCT DESCRIPTION: SYRINGE 10ML LL BNS. SYR 3ML L/L. SYRINGE 5ML LL BNS. VENDOR PART #: 304657. 301073. 304656. LOT #: 5007061. UNKNOWN. (B)(6).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1