BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LL BN

    MDR report key: 23631220 · Received November 24, 2025

    Report

    Report Number
    1911916-2025-00762
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 25, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903010318
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT BROWN PARTICULATE MATTER WAS PRESENT ON A SYRINGE WITHIN THE PLUNGER. TO SUPPORT THE INVESTIGATION, ONE UNPACKAGED SAMPLE AND A PHOTOGRAPH WERE PROVIDED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION WAS CONDUCTED, REVEALING THAT THE SYRINGE PLUNGER ROD HAD A PARTICLE ATTACHED TO ITS BOTTOM WITH A PIECE OF TAPE. THE PHOTOGRAPH CONFIRMED THE CONDITION OF THE RECEIVED SAMPLE. NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE WAS SUBSEQUENTLY SENT TO A LABORATORY FOR ANALYSIS; HOWEVER, THE RESULTS WERE INCONCLUSIVE BECAUSE THE FOREIGN MATTER WAS AFFIXED TO TAPE, WHICH INTERFERED WITH IDENTIFICATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR MATERIAL NUMBER 301031, LOT 5153591. THE REVIEW DID NOT INDICATE ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED, AND ALL PROCESSES AND FINAL INSPECTIONS WERE COMPLETED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND THE RETURNED SAMPLE ANALYSIS, THE CUSTOMER¿S REPORTED OBSERVATION HAS BEEN CONFIRMED.

    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

    IT WAS REPORTED THAT THE BD SYRINGE 20ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #301031 BATCH #5153591. RCC RECEIVED A COMPLAINT VIA EMAIL. BROWN PARTICLE ON 20CC SYRINGE WITHIN THE PLUNGER, WAS THERE AN INJURY - NO, WAS THERE A DEATH - NO. NOTED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310585 BD SYRINGE 20ML LL BN PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5153591 00382903010318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown