BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 7861356 · Received September 10, 2018

    Report

    Report Number
    1213809-2018-00596
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Date of Event
    August 14, 2018
    Report Date
    September 18, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903097020
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE LOOSE 3ML ASSEMBLED SYRINGE WAS RECEIVED AND REPORTED TO BE FROM BATCH #8092641 (P/N 309702). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE HAS A LABEL ATTACHED TO THE BARREL WALL AND A TAN TIP CAP ATTACHED TO THE BARREL TIP. THREE LIGHT BROWN PIECES OF EMBEDDED FOREIGN MATTER WERE OBSERVED. EMBEDDED FOREIGN MATTER LARGER THAN LEVEL 3 IS REJECTABLE PER PRODUCT SPECIFICATION. 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. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER IS ASSOCIATED WITH THE MOLDING PROCESS. 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 THERE WAS BROWN FOREIGN MATTER IN THE BD LUER-LOK SYRINGE BARREL. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    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 THERE WAS BROWN FOREIGN MATTER IN THE BD LUER-LOK¿ SYRINGE BARREL. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703906 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8092641 30382903097020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other