BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18342202 · Received December 17, 2023

    Report

    Report Number
    1213809-2023-01464
    Event Type
    Malfunction
    Date Received
    December 17, 2023
    Date of Event
    November 28, 2023
    Report Date
    March 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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4)¿ FOLLOW UP MDR FOR DEVICE EVALUATION ONE PHOTO OF 3 ML LUER-LOK SYRINGES WAS RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO REVIEW THE SAMPLES FROM LOT NUMBER 3242479 REGARDING MATERIAL NUMBER 309657. THE IMAGE SHOWS TWO PACKAGES FROM THE TOP WEB SIDE WITH ALL APPLICABLE PRODUCT INFORMATION AND TWO LOOSE SYRINGES WITH NO DEFECTS OBSERVED AND THE OTHER WITH ALL SCALE MARKINGS MISSING. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3242479 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGES HAD A SCALE MARKING ISUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INTIAL REPORTER: " APPROXIMATELY 20 309657 3ML SYRINGES WERE FOUND WITHOUT ANY MARKINGS ON THE BARREL. ALL SYRINGES WERE PART OF LOT#3242479, THOUGH OTHER SYRINGES IN THE LOT WERE NOT IMPACTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2275351 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3242479 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown