BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL BNS

    MDR report key: 22163116 · Received June 7, 2025

    Report

    Report Number
    1911916-2025-00399
    Event Type
    Malfunction
    Date Received
    June 7, 2025
    Date of Event
    May 1, 2025
    Report Date
    June 10, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903010313
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THERE WAS EMBEDDED FOREIGN MATTER, PLASTIC ON THE TIP, THREADS ON THE PLUNGER AND SCALE MARKING ISSUES. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 301031 AND POSSIBLE LOT NUMBERS 3352762 AND 4080684. 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

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED: EMBEDDED MATTER (SIMILAR AS SAMPLES THAT WERE SENT): 12 EVENT DETAILS: WE HEREBY SUBMIT OUR FINDINGS AT THE END OF BATCH, AS AGREED UPON. ALL DEVIATIONS WERE FOUND DURING PACKAGING, PRIOR TO STERILIZATION. SO, PRIOR TO USE, SO NO MEDICATION AND NO PATIENTS ARE INVOLVED. EMBEDDED MATTER (SIMILAR AS SAMPLES THAT WERE SENT): 12 PLASTICS ON TIP (SIMILAR AS SAMPLES THAT WERE SENT): 15 THREADS ON PLUNGER (SIMILAR AS SAMPLES THAT WERE SENT): 385 SCALE MARKING (THICK PRINTED): 5. NOT SUBMITTED YET, BUT VERY LOW RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391837 SYRINGE 20ML LL BNS SYRINGE, PISTON FMF BECTON DICKINSON UNKNOWN 50382903010313

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown