BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21566514 · Received March 10, 2025

    Report

    Report Number
    1213809-2025-00179
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    December 19, 2024
    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
    MA, 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. FIFTY-NINE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE SAMPLES WERE RECEIVED IN THREE DIFFERENT BAGS. ONE BAG CONTAINED TWENTY-NINE SYRINGES LABELED AS CRACKS, THE SECOND BAG CONTAINED TWENTY-THREE SYRINGES LABELED AS PARTICULATES, AND THE THIRD BAG CONTAINED SEVEN SYRINGES LABELED AS DISCOLORED. FIFTY-SEVEN SYRINGES WERE FOUND TO BE ACCEPTABLE WITH NO DEFECTS FOUND, AND TWO SYRINGES WERE OBSERVED TO HAVE BROWNISH DISCOLORATION EMBEDDED IN THE BARREL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START-UP. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE A RISK TO THE CUSTOMER. THE REPORTED DEFECTS OF PARTICULATE AND BARREL CRACKS WERE NOT IDENTIFIED IN THE SAMPLES RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4213833. 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#:4213833. IT WAS REPORTED THAT THE BD LUER-LOK BARREL WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. 800 SYRINGES INSPECTED BY QA AND 59 SYRINGES WERE SET ASIDE TO BE REJECTED DUE TO PARTICLES WITHIN PACKAGING AND DISCOLORATION/CRACKS ON THE SYRINGES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2090839 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4213833 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown