BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL BNS

    MDR report key: 24621406 · Received March 17, 2026

    Report

    Report Number
    1911916-2026-00124
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 12, 2026
    Report Date
    April 1, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903010332
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. FLASH IN THE FLUID PATH, CRACKS, AND EMBEDDED PARTICLES WERE REPORTED. TO SUPPORT THE INVESTIGATION, THIRTEEN BULK PACKAGED SAMPLES, RECEIVED IN A PLASTIC BAG, AND FIVE PHOTOGRAPHS WERE PROVIDED TO THE QUALITY TEAM FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SAMPLES. ONE SAMPLE CONTAINED AN EMBEDDED DARK COLORED SPECK, AND ONE SAMPLE EXHIBITED DAMAGE TO THE LUER LOCK TIP. BARREL TIP FLASH WAS OBSERVED ON EACH SYRINGE, HOWEVER, THE FLASH MEASUREMENTS WERE WITHIN SPECIFICATION. THE FIVE PHOTOGRAPHS SUPPLIED DEPICT A SUBSET OF THE SAMPLES RECEIVED. NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE IDENTIFIED DURING THE EVALUATION. EMBEDDED, DEGRADED RESIN IN MOLDED COMPONENTS TYPICALLY OCCURS DURING START UP OR INTERMITTENTLY THROUGHOUT THE INJECTION MOLDING PROCESS AND CAN SEPARATE AND BECOME INCORPORATED INTO PARTS DURING MOLDING. BARREL DAMAGE MAY OCCUR IF A JAM IS ENCOUNTERED DURING THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 301033, LOT 5154744. THE REVIEW DID NOT IDENTIFY ANY MANUFACTURING OR INSPECTION ISSUES THAT WOULD BE EXPECTED TO CONTRIBUTE TO THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE ASSOCIATED WITH THIS LOT. ALL PRODUCTION STEPS AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. IN ADDITION, VERIFICATION OF THE ASSEMBLY PROCESS WAS CONDUCTED, CONFIRMING THAT RAILS AND CONVEYORS WERE PROPERLY ALIGNED AND THAT PRODUCT FLOW THROUGH THE PROCESS WAS ACCEPTABLE. BASED ON THE INVESTIGATION, INCLUDING ANALYSIS OF THE RETURNED SAMPLES, THE CUSTOMER REPORTED SYMPTOMS ARE CONFIRMED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER EMBEDDED PARTICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414856 SYRINGE 30ML LL BNS SYRINGE, PISTON FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5154744 00382903010332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown