BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21547090 · Received March 7, 2025

    Report

    Report Number
    1213809-2025-00172
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 13, 2025
    Report Date
    April 28, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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) - SUPPLEMENTAL MDR - SCALE MARKING ISSUE. TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON PHOTOS EVALUATION, IT WAS OBSERVED THAT THE SCALE MARKINGS WERE SKEWED, AND MORE THAN 50% OF THE GRAD LINES WERE MISSING. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. THE POTENTIAL ROOT CAUSE OF THE SKEWED PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS AND MISSING PRINT DEFECT ASSOCIATED WITH THE ASSEMBLY PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3041968. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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#: 309628, BATCH#: 3041968. IT WAS REPORTED THAT THE BD LUER-LOK HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. "ON DOS ON (B)(6) 2025, DR. PROCEEDED WITH TREATMENT FOR PATIENT WITH ANOTHER VIAL DUE TO THE SYRINGE BEING DAMAGED." BASED ON THE PICTURE PROVIDED IT WAS SCALE MARKING ISSUE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437260 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3041968 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown