BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 17982103 · Received October 21, 2023

    Report

    Report Number
    1213809-2023-01164
    Event Type
    Malfunction
    Date Received
    October 21, 2023
    Date of Event
    October 4, 2023
    Report Date
    February 2, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 9011906 - FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED THE SYRINGES HAVE NO GRADUATIONS. TO AID IN THE INVESTIGATION, THREE PHOTOS OF A 3ML LUER LOK SYRINGE FROM LOT 3209795 WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. TWO IMAGES SHOW THE TOP WEB SIDE OF A PACKAGE FROM TWO DIFFERENCE ANGLES WITH ALL APPLICABLE PRODUCT INFORMATION. THE THIRD IMAGE SHOWS A SYRINGE IN A SEALED PACKAGE WITH ALL THE SCALE MARKINGS MISSING. THE CONDITION OBSERVED IN NON-CONFORMING PER PRODUCT SPECIFICATION AND IS ASSOCIATED WITH THE MARKING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309657, LOT 3209795. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOT 3209795 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 ITS 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 3ML SYRINGES HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE "3ML SYRINGES WITH NO GRADUATIONS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996715 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3209795 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown