BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18489752 · Received January 10, 2024

    Report

    Report Number
    1213809-2023-01530
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    December 19, 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

    PR 9448212¿ FOLLOW UP MDR FOR DEVICE EVALUATION ONE SAMPLE AND ONE PHOTO OF A 3 ML LUER-LOK SYRINGE WERE RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO REVIEW THE SAMPLE AND PHOTO FROM LOT NUMBER 3242479 REGARDING MATERIAL NUMBER 309657. THE SAMPLE WAS RECEIVED WITH THE PACKAGE WITH ALL APPLICABLE PRODUCT INFORMATION ON THE TOP WEB AND SYRINGE MISSING ALL SCALE MARKINGS. THE IMAGE SHOWS A LOOSE SYRINGE WITH ALL THE 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. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, 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 SYRINGE HAD A SCALE MARKING ISSUE. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: "REMOVED 3ML SYRINGE FROM PACKAGE AND FOUND THAT THERE WERE NOT NUMBERS OR DASHES TO DETERMINE HOW MANY MLS WERE PLACED IN SYRINGE." TYPE OF PRODUCT 3 ML STERILE SYRINGE PRODUCT REF # (B)(4). PRODUCT LOT # 3242479.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647077 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3242479 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown