BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19495376 · Received June 9, 2024

    Report

    Report Number
    1213809-2024-00358
    Event Type
    Malfunction
    Date Received
    June 9, 2024
    Date of Event
    May 28, 2024
    Report Date
    December 6, 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
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: ADDRESS WAS NOT LOCATED AND IL WAS USED. H3: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ONE SAMPLE AND ONE PHOTO OF A 3 ML LL (P/N: 309657, BATCH: 4101730) WERE RECEIVED AND EVALUATED. THE PICTURE, TAKEN FROM THE BOTTOM WEB PERSPECTIVE, SHOWS A BLANK SYRINGE IN WHAT APPEARS TO BE A 3 ML SEALED PACKAGE. THE SAMPLE ARRIVED IN A FULLY SEALED PACKAGE WITH NO SCALE MARKINGS. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. THE POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER: 4101730 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

    MATERIAL # 309657. LOT # 4101730. IT WAS REPORTED THAT THE BD LUER-LOK HAD A SCALE MARKING ISSUE, THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "3ML SYRINGE HAS NO MEASUREMENT MARKINGS ON THE BARREL."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319073 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4101730 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown