BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML L/T SSU NRFIT

    MDR report key: 23722296 · Received December 4, 2025

    Report

    Report Number
    1911916-2025-00777
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 11, 2025
    Report Date
    December 17, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    QEH
    UDI-DI
    00382904001827
    PMA / PMN Number
    K192538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT BLACK SPOTS WERE PRESENT INSIDE THE CONNECTION. TO SUPPORT THE INVESTIGATION, ONE SAMPLE WITHOUT BLISTER PACKAGING AND TWO PHOTOGRAPHS WERE PROVIDED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION WAS CONDUCTED. THE SYRINGE BARRELS LUER-LOK AND LUER TIP EXHIBIT DARK SPECKS OF EMBEDDED DEGRADED RESIN. THE TWO PHOTOGRAPHS DEPICT THE SAME SAMPLE THAT WAS RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. EMBEDDED DEGRADED RESIN IN COMPONENTS TYPICALLY OCCURS AT STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS; THE DEGRADED MATERIAL CAN DISLODGE AND BECOME INCORPORATED INTO MOLDED PARTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 400812, LOT 4080696. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER REPORTED CONDITION IS CONFIRMED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 20ML L/T SSU NRFIT HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT BLACK SPOTS ON THE INSIDE OF THE NRF CONNECTION (SEE ATTACHMENT) ADDITIONAL INFORMATION PROVIDED: 1. COULD YOU PLEASE CONFIRM THE MATERIAL NUMBER OF THE PRODUCT? SKU 400182 - LOT 4080696. 2. IT CAME TO OUR ATTENTION THAT SAMPLES ARE AVAILABLE FOR INVESTIGATION. COULD YOU PLEASE SPECIFY IF THE SAMPLES ARE: UNUSED (BEFORE USE) THE SYRINGE IS UNUSED, BUT THE PACKAGING HAS BEEN OPENED, SO ONLY THE SYRINGE IS AVAILABLE. USED (DURING OR AFTER USE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2447133 BD SYRINGE 20ML L/T SSU NRFIT PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT QEH BD MEDICAL (BD WEST) MEDICAL SURGICAL 4080696 00382904001827

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown