BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21379521 · Received February 13, 2025

    Report

    Report Number
    1213809-2025-00091
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    January 21, 2025
    Report Date
    April 13, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)- SUPPLEMENTAL MDR - OTHER TWO HUNDRED SAMPLES FROM BATCH 4263689 AND TWO HUNDRED SAMPLES FROM BATCH 4263696 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ACCORDING TO VERBATIM, THE COMPLAINT APPEARS TO BE FOR THE ABSENCE OF STOP RING ON THE PLUNGER ROD. THIS PRODUCT DOES NOT HAVE A STOP RING BY DESIGN ACCORDING TO ITS PRODUCT SPECIFICATION. BATCHES 3285600, 4033569, 4158490, 4263689 AND 4263689 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    D.4. OTHER LOT NUMBERS INCLUDE 4033569, 4158490, 4263689 AND 4263696. OTHER EXPIRATION DATES INCLUDE 2029-01-31, 2029-05-31 AND 2029-08-31. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATES ARE 2024-02-14, 2024-07-15 AND 2024-09-19.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK PLUNGER "DOES COME OUT QUITE EASILY IF THE PLUNGER IS PULLED". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO RESISTANCE AT THE END OF TRAVEL. IT DOES COME OUT QUITE EASILY IF THE PLUNGER IS PULLED WITHOUT PAYING ATTENTION WHEN USING THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125840 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3285600 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown