BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18253625 · Received December 3, 2023

    Report

    Report Number
    1213809-2023-01377
    Event Type
    Malfunction
    Date Received
    December 3, 2023
    Date of Event
    November 3, 2023
    Report Date
    January 4, 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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 9220524¿ FOLLOW UP MDR FOR DEVICE EVALUATION. ONE-HUNDRED AND NINETY-NINE SAMPLES OF 3ML LUER-LOCK SYRINGES WERE RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO REVIEW THE SAMPLES FROM LOT #3209797 REGARDING ITEM #309657. 197 SAMPLES WERE RECEIVED IN SEALED PACKAGES AND 2 IN OPENED PACKAGES. ALL 199 SAMPLES HAD MISSING PRINT WITH NO SCALE MARKINGS AT ALL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THE FOLLOWING CORRECTIVE ACTIONS WILL BE TAKEN: RE-EDUCATION OF ASSOCIATES INVOLVED IN BATCH MANUFACTURE TO APPLICABLE PROCEDURES. SEND QUALITY ALERT TO MANUFACTURING PLANT TO NOTIFY ALL ASSOCIATES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 3209797 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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 THE BD LUER-LOK SYINGES HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "3ML SYRINGES MISSING THE MEASUREMENT MARKINGS ON THE SYRINGE. WE HAVE RECEIVED MORE COMPLAINTS FROM OTHER SITES SINCE MONDAY. YESTERDAY I HEARD REPORTS FROM (B)(6)." (B)(3) 2023. PLEASE PROVIDE THE OCCURRENCE DATE. (B)(3) 2023. IS THERE ANY ADVERSE EVENT TO PATIENT DUE TO THE INCIDENT? DELAYED PATIENT CARE. IS PHOTO AVAILABLE FOR REVIEW? SEE BELOW. IS SAMPLE AVAILABLE FOR RETURN? IF YES, PLEASE PROVIDE YOUR ADDRESS FOR RETURN LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604551 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3209797 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown