BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23818247 · Received December 16, 2025

    Report

    Report Number
    1911916-2025-00805
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 19, 2025
    Report Date
    January 8, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903028306
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Additional Manufacturer Narrative · 0

    (B)(6) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT BLACK SPECKS WERE OBSERVED IN THE SYRINGE. TO SUPPORT THE INVESTIGATION, ONE SAMPLE IN AN OPENED BLISTER PACK WAS RECEIVED AND EVALUATED BY THE QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AT 10X AND THEN 30X MAGNIFICATION NO DEFECTS, IMPERFECTIONS, OR FOREIGN MATERIAL WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 302830, LOT 5212126. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE ISSUED, AND ALL PROCESSES AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION, INCLUDING ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER REPORTED CONDITION COULD NOT BE 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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 48 HAD FOREIGN MATTER. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTED: MATERIAL#: 302830, BATCH#: 5212126 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: YES, ITEM: 302830, QUANTITY AFFECTED: (B)(4) EA SERIAL/LOT NUMBER: (B)(6). PO: (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? NO. ARE SAMPLES POTENTIALLY CONTAMINATED OR BIOHAZARD? N/A. REPORTED ISSUE: DR. WAS DRAWING PROPOFOL INTO A 20 ML SYRINGE PRIOR TO THE PATIENT ENTERING OR 6 WHEN HE NOTICED SMALL DARK GRAY/BLACK SPECKS IN HIS SYRINGE. A MINI SPIKE WAS USED, AND NO DARK FLAKES OF ANY KIND WERE SEEN WITHIN THE VIAL OF MEDICATION. THE COLORING MATCHED THE RUBBER PLUNGER WITHIN THE SYRINGE. THE VIAL AND SYRINGE WERE DISPOSED OF BY DR. FOR PATIENT SAFETY REASONS, AND A NEW VIAL AND SYRINGE WERE USED FOR THE CASE. NOTED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2282786 BD LUER-LOK PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5212126 00382903028306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown