BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 23432787 · Received October 30, 2025

    Report

    Report Number
    1213809-2025-00689
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 16, 2025
    Report Date
    December 3, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP IT WAS REPORTED THAT BLACK SPECKS WERE PRESENT ON BOTH THE EXTERIOR AND INTERIOR SURFACES OF THE SYRINGE BARRELS. BECAUSE A PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE PERFORMED. TO SUPPORT THE INVESTIGATION, ONE PHOTOGRAPH OF A 5 ML LUER-LOK SYRINGE WAS PROVIDED FOR REVIEW BY THE QUALITY TEAM. THE IMAGE SHOWS TWO LOOSE SYRINGES, EACH DISPLAYING MULTIPLE UNIDENTIFIED BLACK MARKINGS ON THE BARRELS. BASED ON THE PHOTOGRAPH ALONE, IT IS NOT POSSIBLE TO CONFIRM WHETHER THE FOREIGN MATTER IS LOCATED INSIDE OR OUTSIDE THE FLUID PATH, NOR WHETHER IT IS LOOSE, PRINTED, OR EMBEDDED. WHILE THE OBSERVED CONDITION DOES NOT CONFORM TO PRODUCT SPECIFICATIONS, THE POTENTIAL ROOT CAUSE CANNOT BE DETERMINED FROM THE PHOTO ALONE. A PHYSICAL SAMPLE IS REQUIRED TO CONDUCT A THOROUGH EVALUATION AND IDENTIFY THE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR MATERIAL NUMBER 301027, LOT 5150312. THE REVIEW CONFIRMED THAT ALL VISUAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH REQUIREMENTS, AND NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. THE LOT WAS INSPECTED AND ACCEPTED BASED ON THE APPROVED INSPECTION CONTROL PLAN, RELEASED FOR SHIPMENT, AND DEEMED COMPLIANT WITH PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #301027. LOT #5150312. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE ENCOUNTER 1 CASE (1400) OF ITEM 301027 ¿ LOT 5150312 RECEIVED UNDER (B)(4) THAT HAVE BLACK SPECS ON THE EXTERIOR AND INTERIOR OF THE BARRELS. SOME SPECS ARE LOOSE AND MOVE WHEN TOUCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299443 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5150312

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown