BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23950392 · Received January 2, 2026

    Report

    Report Number
    1911916-2025-00827
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 11, 2025
    Report Date
    January 9, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT WHITE PARTICULATES WERE PRESENT INSIDE SYRINGES. TO SUPPORT THE INVESTIGATION, OUR QUALITY TEAM RECEIVED TWO SAMPLES WITH OPENED BLISTER PACKAGING AND TWO PHOTOGRAPHS FOR EVALUATION. A VISUAL INSPECTION IDENTIFIED DROPLETS OF SOLUTION WITHIN THE SYRINGES; ONE SYRINGE ALSO EXHIBITED A DROPLET OF LUBRICANT ON THE RUBBER STOPPER. THE PHOTOGRAPHS CORRESPOND TO THE SAMPLES RECEIVED. THE LUBRICANT IS MEDICAL GRADE AND IS APPLIED TO THE INNER WALL OF THE SYRINGE BARREL AND TO THE RUBBER STOPPER; ITS PRESENCE IN THIS MANNER IS ACCEPTABLE. A REVIEW OF THE DEVICE HISTORY RECORD FOR MATERIAL NUMBER 309653, LOT 5232842, IDENTIFIED NO QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. 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 THE SAMPLES, THE CUSTOMER REPORTED CONDITION WAS CONFIRMED AND IS CONSIDERED ACCEPTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 50 ML LL TIP 1 ML CONTAINED FOREIGN MATTER. VERBATIM: WE DISCOVERED THAT A COUPLE OF OUR 50 ML SYRINGES FROM BD HAD WHITE PARTICULATES INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3108 BD LUER-LOK PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5232842 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other