BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE 5ML LL SP125

    MDR report key: 8116548 · Received November 29, 2018

    Report

    Report Number
    1213809-2018-00836
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    November 12, 2018
    Report Date
    January 23, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A SINGLE SEALED PACKAGED 5ML LL SYRINGE WAS RECEIVED, CONFIRMED TO BE FROM BATCH #8242796 (P/N 309646). A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: IT WAS VISUALLY EVALUATED. A REDDISH-BROWN LOOSE FOREIGN MATTER WAS OBSERVED COVERING THE INSIDE OF THE LUER COLLAR OF THE SYRINGE OUTSIDE THE FLUID PATH. THE FOREIGN MATTER WAS ONLY OBSERVED IN THE COLLAR AND NOT FOUND IN OR ON THE TIP, NOR WAS IT OBSERVED ELSEWHERE ON THE BARREL. THE FOREIGN MATTER IS MOST LIKELY GREASE RESIDUE FROM THE MOLDING PRESS. ROOT CAUSE DESCRIPTION: POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. RATIONALE: NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. 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 BD LUER-LOK SYRINGE 5ML LL SP125 HAD FOREIGN MATTER ON THE TIP.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD LUER-LOK SYRINGE 5ML LL SP125 HAD FOREIGN MATTER ON THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958021 BD LUER-LOK SYRINGE 5ML LL SP125 GENERAL-PURPOSE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8242796 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 Other