BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 22800382 · Received August 13, 2025

    Report

    Report Number
    1911916-2025-00571
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    February 26, 2025
    Report Date
    August 20, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THERE IS THE PRESENCE OF A PARTICULATE. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 309653 AND LOT NUMBERS 3275084 AND 4080184. 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. DUE TO THE UNAVAILABILITY OF A SAMPLE FOR RETURN, A COMPREHENSIVE SAMPLE INVESTIGATION COULD NOT BE CONDUCTED. CONSEQUENTLY, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNDETERMINED. SHOULD YOU ENCOUNTER ANY FURTHER ISSUES WITH OUR PRODUCT, WE WOULD APPRECIATE THE OPPORTUNITY TO PERFORM A DETAILED ANALYSIS. AT THIS TIME, NO FURTHER ACTION IS DEEMED NECESSARY.

    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 IS REPORTED FOREIGN MATTER. EVENT DESCRIPTION: WE HAVE A SET OF QUESTIONS TO PASS ALONG TO THE BD REPS. WE ARE INVESTIGATING THE PRESENCE OF A PARTICULATE IN A SAMPLE, SO WE ARE CHECKING WITH VENDORS ON THEIR PROCESSES FOR ALL THE INVOLVED COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829654 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4080184 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown