BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LL BNS

    MDR report key: 23771032 · Received December 10, 2025

    Report

    Report Number
    1911916-2025-00784
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 14, 2025
    Report Date
    December 15, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. DEVIATIONS WERE REPORTED DURING THE PACKAGING PROCESS. TO SUPPORT THE INVESTIGATION, NINETEEN SAMPLES CONTAINED IN FIVE SEPARATE BAGS WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. THE BAG LABELED ¿SCALE MARKING¿ CONTAINED FOUR SAMPLES, ALL OF WHICH WERE ACCEPTABLE. GRADUATION LINES WERE CLEAR, AND THE NUMBERS WERE LEGIBLE. THE BAG LABELED ¿PLASTIC FLASH ON THE TIP¿ INCLUDED SIX SAMPLES; MEASUREMENTS CONFIRMED THAT ALL FLASH VALUES WERE WITHIN SPECIFICATION LIMITS. THE BAG LABELED ¿PLASTIC THREAD ON THE PLUNGER¿ CONTAINED FOUR SAMPLES, EACH DEEMED ACCEPTABLE AND NOT DEFECTIVE. THE BAG LABELED ¿EMBEDDED MATTER¿ INCLUDED FOUR SAMPLES, WITH SYRINGE BARRELS EXHIBITING AN EMBEDDED DARK-COLORED SPECK. THE FINAL BAG, LABELED ¿DIRT,¿ CONTAINED ONE SAMPLE WITH TWO EMBEDDED, BROWN-COLORED SPECKS. NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE OBSERVED. EMBEDDED DEGRADED RESIN IN COMPONENTS TYPICALLY OCCURS DURING STARTUP OR INTERMITTENTLY THROUGHOUT THE INJECTION MOLDING PROCESS, AS DEGRADED RESIN CAN BREAK LOOSE AND BECOME MOLDED INTO PARTS. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 301031, LOT 4080684. THE REVIEW REVEALED NO QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED, AND ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF RETURNED SAMPLES, THE CUSTOMER¿S REPORTED SYMPTOM OF EMBEDDED FOREIGN MATTER 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: WE JUST FINISHED THE PACKAGING OF THE 20ML SYRINGES AND WE HEREBY SUBMIT THE DEVIATIONS FOUND. ALL DEVIATIONS WERE FOUND DURING PACKAGING, PRIOR TO USE, SO NO PATIENTS WERE INVOLVED. EVENT DATE: 14/11/2025. ARTICLE CODE: 301031, 20 ML LL NS BULK. DURING THIS PRODUCTION THE FOLLOWING BATCH NUMBERS WERE USED. IT CANNOT BE DETERMINED WHICH DEVIATION CAME FROM WHAT BATCH. DEVIATIONS: 82 X SYRINGE WITH PLASTIC FLASH ON TIP. 151 X SYRINGE WITH PLASTIC THREAD ON PLUNGER ROD. 30 X SYRINGE WITH SCALE MARKING ISSUES (CROOKED, MISSING). 23 X SYRINGE WITH EMBEDDED MATTER. ADDITIONAL INFORMATION PROVIDED: THE 23 SAMPLES HAD THE EMBEDDED MATTER NOT ON ONE PARTICULAR SPOT, SO PLEASE INSPECT THE SAMPLES FOR THE EXACT LOCATIONS. IT WAS NOT PARTICULARLY WITHIN THE FLUID PATH AS IN ABOVE THE STOPPER, BUT IT WAS ALSO ON THE PISTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107318 BD SYRINGE 20ML LL BNS PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 4080684

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown