BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 21973115 · Received May 6, 2025

    Report

    Report Number
    1213809-2025-00325
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    April 1, 2025
    Report Date
    June 27, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 - BARREL CRACKED. SEVENTY SEALED SAMPLES OF 10ML LUER-LOK SYRINGES (PART NUMBER 302995, BATCH 5030615) WERE RECEIVED AND EVALUATED. SIXTY-THREE SAMPLES SHOWED NO DEFECTS AND WERE CONSIDERED ACCEPTABLE. SEVEN SAMPLES HAD CRACKS IN THE BARREL, AND FOUR OF THOSE WERE FOUND TO LEAK. THIS CONDITION IS NON-CONFORMING PER PRODUCT SPECIFICATIONS. POTENTIAL ROOT CAUSE FOR THE BARREL CRACKED DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 5030615. 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

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 BARREL WAS CRACKED. BECTON, DICKINSON 10 ML SYRINGE SERINGUE LUER-LOG TIP, LOT: 5030615, REF: 302995 SYRINGES ARE CRACKED. AND LEAKING, SOME CRACKS ARE LARGE AND VISIBLE, AND SOME ARE LESS VISIBLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469874 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5030615 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown