BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19591653 · Received June 23, 2024

    Report

    Report Number
    1213809-2024-00408
    Event Type
    Malfunction
    Date Received
    June 23, 2024
    Date of Event
    June 10, 2024
    Report Date
    December 6, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    FOUR PHOTOS OF A 1ML LUER-LOK SYRINGE (P/N - 309628) BATCH 1323389 WERE RECEIVED AND EVALUATED. THREE OF THE PHOTOS SHOW ONE LOOSE SYRINGE WITH THE SCALE MARKINGS MISSING ON A LARGE PORTION OF THE BARREL. TWO OF THE PHOTOS SHOW THE TOP WEB PORTION OF THE PACKAGE INCLUDING ALL APPLICABLE PRODUCT INFORMATION. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE SCALE MARKINGS MISSING 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 1323389 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 HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENLGISH: "SANOFI WAS TESTING SEVERAL SAMPLE SERINGES FOR THEIR DRUG ON MONDAY, ON (B)(6) 2024 AT 10:20 AM. WHEN TESTING THE BD SYRINGE (BATCH 132389), PRINTING ERASED ITSELF. ANOTHER BATCH WAS TESTED (BATCH 1348444) AND THE PRINTING DIDN'T ERASED ITSELF." WHEN WAS ISSUE DETECTED? PRIOR TO USE SAMPLE/ PHOTO AVAILABLE FOR RETURN PICTURE ONLY - SAMPLE NOT AVAILABLE

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201270 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1323389 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown