BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23977765 · Received January 6, 2026

    Report

    Report Number
    1911916-2025-00832
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 14, 2025
    Report Date
    January 10, 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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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. A COMPLAINT WAS RECEIVED ALLEGING A BLACK SPOT ON THE SYRINGE PLUNGER. TO SUPPORT THE INVESTIGATION, THE QUALITY TEAM RECEIVED ONE SAMPLE IN AN OPENED BLISTER, THREE SAMPLES IN SEALED BLISTERS, AND THREE PHOTOGRAPHS. VISUAL INSPECTION OF THE SAMPLES WAS PERFORMED UNDER 20X AND 30X MAGNIFICATION. ONE SAMPLE EXHIBITED AN EMBEDDED DARK SPECK WITHIN A RIB OF THE PLUNGER ROD; ANOTHER EXHIBITED AN EMBEDDED DARK SPECK IN THE SYRINGE BARREL. THE EMBEDDED PARTICULATES OBSERVED WERE WITHIN ACCEPTABLE SIZE LIMITS. THE REMAINING TWO SAMPLES EXHIBITED NO DEFECTS OR IMPERFECTIONS. THE THREE PHOTOGRAPHS PROVIDED WERE BLURRY, PRECLUDING OBSERVATION OF THE REPORTED CONDITION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 309653, LOT 5212937. THE REVIEW REVEALED NO QUALITY ISSUES DURING MANUFACTURE THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH APPLICABLE SPECIFICATIONS. TO DATE, NO ADDITIONAL SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND SAMPLE ANALYSIS, THE CUSTOMER REPORTED SYMPTOM IS CONFIRMED; HOWEVER, THE CONDITION OBSERVED IS WITHIN SPECIFICATION AND CONSIDERED ACCEPTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 50ML LL TIP 1ML CONTAINED FOREIGN MATTER. 50ML SYRINGES HAVE BLACK SPECKS ON THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37951 BD LUER-LOK PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5212937 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other