BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23361916 · Received October 22, 2025

    Report

    Report Number
    1911916-2025-00692
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    October 2, 2025
    Report Date
    October 24, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903028320
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP FLUID WAS REPORTED TO HAVE EMERGED FROM THE INNER WALL OF THE SYRINGE PLUNGER. AS NO PHYSICAL SAMPLE WAS RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. TO SUPPORT THE INVESTIGATION, ONE PHOTOGRAPH WAS PROVIDED AND REVIEWED BY THE QUALITY TEAM. THE IMAGE DEPICTS TWO SYRINGES ENCLOSED IN A PLASTIC BAG, BOTH WITH THE PLUNGER ROD AND RUBBER STOPPER POSITIONED AT THE 1 ML MARK ON THE SYRINGE BARREL SCALE. ONE SYRINGE APPEARS TO SHOW FLUID AT THE BOTTOM RIB OF THE RUBBER STOPPER. NO ADDITIONAL DEFECTS OR IRREGULARITIES WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR MATERIAL NUMBER 302832, LOT 5183106. THE ASSESSMENT DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND THE PHOTOGRAPHIC EVIDENCE PROVIDED, THE SYMPTOM DESCRIBED BY THE CUSTOMER HAS BEEN CONFIRMED. HOWEVER, IN THE ABSENCE OF A PHYSICAL SAMPLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    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 30ML LL S/C 56 HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 302832. BATCH#: 5183106. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. OUR IV TECHNICIAN TRIED TO USE THEM TO COMPOUND IN THE IV RM AND THE FLUID CAME OUT OF THE INNER WALL OF THE SYRINGE/PLUNGER. N/A THIS HAPPENED IN PHARMACY WHILE COMPOUNDING. 30ML SYRINES REF # (B)(4) LOT # 5183106.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232513 BD LUER-LOK PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5183106 00382903028320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown