BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 17971429 · Received October 19, 2023

    Report

    Report Number
    1213809-2023-01152
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    October 2, 2023
    Report Date
    January 25, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)¿ FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS A MOLD-LIKE CONTAMINATION. TO AID IN THE INVESTIGATION, ONE SAMPLE OF A 3ML LUER LOK SYRINGE FROM LOT 3083721 WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SYRINGE HAS AN EMBEDDED GREY FOREIGN MATTER AT THE GATE AREA OF THE BARREL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE A RISK TO THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309657, LOT 3083721. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOT 3083721 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN, SUBSEQUENTLY APPROVED FOR SHIPMENT AND IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. THIS CONDITION IS OCCURRING AT OR BELOW IS EXPECTED FREQUENCY; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK SYRINGE CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE OF THE SYRINGES NEAR THE BOTTOM HAS 'MOLD-LIKE' CONTAMINATION." HOW MANY SYRINGES HAVE THIS ¿MOLD-LIKE¿ FOREIGN MATTER? ONE IDENTIFIED . ARE YOU ABLE TO DESCRIBE THE LOCATION OF THE FOREIGN MATTER, EITHER IN FLUID PATHWAY (IN BARREL/ON STOPPER/ETC.) OR NOT IN FLUID PATHWAY (OUTSIDE OF THE BARREL/ ON FLANGE/ETC.) NOT ON FLUID? PATHWAY¿APPEARS TO BE INSIDE THE PLASTIC. WAS THERE ANY PATIENT INVOLVEMENT? NO. WHAT WAS THE PATIENT'S OUTCOME? N/A. WHAT PROCEDURE WAS BEING PERFORMED? IV COMPOUNDING. WHAT MEDICATION WAS USED? UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203714 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3083721 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown