BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21306250 · Received February 4, 2025

    Report

    Report Number
    1213809-2025-00067
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    January 16, 2025
    Report Date
    February 19, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096597
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. D.4. OTHER LOT NUMBER INCLUDES 4040291 AND OTHER EXPIRATION DATE INCLUDES 2029-01-31. 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 DATE IS 2024-02-09.

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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.

    Description of Event or Problem · 0

    MATERIAL # 309659 BATCH # UNKNOWN, 4040291. IT WAS REPORTED BY CUSTOMER THAT WHEN THEY PUT IN PRIMER SOLUTION (CLEAR IN COLOR) AND IT IS TURNING YELLOW. RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE PURCHASED # 309659 AND WITH SEVERAL BATCHES/ LOTS, OUR CUSTOMER IS SAYING WHEN THEY PUT IN PRIMER SOLUTION (CLEAR IN COLOR) AND IT IS TURNING YELLOW (WHICH THEY SAY HAS NEVER HAPPENED BEFORE). THE BATCHES/LOTS THAT HAVE BEEN USED ARE: 3031943, 4040291 AND MOST RECENT 3032625.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363709 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096597

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown