BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23139736 · Received September 24, 2025

    Report

    Report Number
    1911916-2025-00656
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 9, 2025
    Report Date
    September 11, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. ADDRESS WAS NOT LOCATED AND (B)(6) WAS USED. IT WAS REPORTED SOME 30ML SYRINGES ARE CONTAMINATED WITH BLACK PARTICLES. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 302832 AND LOT NUMBER 5091289. THE REVIEW DID NOT IDENTIFY ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE DEFECT, AND ALL QUALITY TESTS WERE WITHIN SPECIFICATION. CONSEQUENTLY, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNDETERMINED. AT THIS TIME, NO FURTHER ACTION IS DEEMED NECESSARY. COMPLAINTS RELATED TO THIS DEVICE AND THE REPORTED CONDITION WILL CONTINUE TO BE MONITORED AND ANALYZED FOR EMERGING TRENDS BY OUR QUALITY TEAM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 30ML LL S/C 56 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 302832 LOT 5091289.     VERBATIM: WE HAVE SOME 30ML SYRINGES THAT ARE CONTAMINATED WITH BLACK PARTICLES. CAN WE OPEN A CASE FOR THESE SPECIFIC LOT NUMBER SYRINGES? THE LOT AFFECTED IS: 5091289. ITS ABOUT 3 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851337 BD LUER-LOK PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5091289

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown