BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LL W/O DN

    MDR report key: 9775324 · Received March 2, 2020

    Report

    Report Number
    1213809-2020-00149
    Event Type
    Malfunction
    Date Received
    March 2, 2020
    Date of Event
    November 11, 2019
    Report Date
    February 11, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE PHOTO OF A LOOSE 1ML SYRINGE WITH AN UNKNOWN NEEDLE ATTACHED WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS SMALL, RED EMBEDDED FOREIGN MATTER PARTICLES IN THE BARREL WALL AT THE 0.05 AND 0.08ML MARKINGS. IT APPEARED TO BE A PIECE OF GASKET FROM THE MOLDING PRESS. THE PARTICLES WERE LARGER THAN LEVEL 2 IN SIZE, WHICH WERE ACCEPTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. IT WAS LIKELY DUE TO A DEGRADED GASKET IN THE MOLDING PRESS. ALL DEGRADED GASKETS WERE REPLACED. FURTHERMORE, 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. 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 · 1

    IT WAS REPORTED THAT THE SYRINGE 1ML LL W/O DN EXPERIENCED FOREIGN MATTER IN THE DEVICE CANNULA/NEEDLE/SYRINGE OR ANY FLUID PATH COMPONENT. THE PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309628 BATCH NO: 9003925. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: ON (B)(6) 2019, THE REPORTER CONTACTED DISTRIBUTOR VIA PHONE TO REQUEST REPLACEMENT OF 1 MEDICATION VIAL(S). THE REPORTER DENIED ANY ADVERSE EVENTS OR MISSED DOSES DUE TO THIS EVENT. PER THE REPORTER, ON (B)(6) 2019, AS THE MEDICATION WAS BEING WITHDRAWN INTO THE SYRINGE, THE TECHNICIAN NOTICED THERE WERE RED DOTS INSIDE OF THE BARREL OF THE SYRINGE. THE MEDICATION WAS NOT USED. THE PATIENT SUCCESSFULLY RECEIVED A DOSE FROM A NEW EYLEA KIT. RETURN RECEIVED BY DISTRIBUTOR QA. COMPLAINT CONFIRMED. DEFECT OBSERVED: RED DOTS INSIDE OF THE BARREL OF THE SYRINGE. DISTRIBUTOR ATTEMPTED TO REMOVE THE RED DOTS. THE SYRINGE BARREL WAS CUT AND IT WAS DETERMINED THAT THE RED DOTS WERE EMBEDDED WITHIN THE SYRINGE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241140 SYRINGE 1ML LL W/O DN PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9003925 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other