BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER LOK¿ SYRINGE

    MDR report key: 7706246 · Received July 20, 2018

    Report

    Report Number
    1213809-2018-00440
    Event Type
    Malfunction
    Date Received
    July 20, 2018
    Date of Event
    June 25, 2018
    Report Date
    August 28, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES.

    Additional Manufacturer Narrative · 0

    ONE PHOTO DEPICTING A SYRINGE WITH THE STOPPER POSITIONED AT THE 1/2ML SCALE, A PIECE OF FOREIGN MATTER LARGER THAN LEVEL THREE OBSERVED IN THE FLUID PATH. THIS APPEARS TO BE AN EXTREME CLOSE UP OF THE PHYSICAL SAMPLES RECEIVED. PHYSICAL SAMPLES - TWO LOOSE 3ML ASSEMBLED SYRINGES WITH TIP CAPS WERE RECEIVED AND REPORTED TO BE FROM BATCH #8088529 OR 8092640 (P/N 309702). THE SAMPLES WERE VISUALLY EVALUATED. THE SYRINGES WERE FOUND TO HAVE UNIDENTIFIED FOREIGN MATTER INSIDE THE FLUID PATH OF EACH SYRINGE. THE FOREIGN MATTER OBSERVED IS GRAY/BLACK IN COLOR AND IS LARGER THAN LEVEL 3 IN SIZE, WHICH IS A REJECTABLE CONDITION PER PRODUCT SPECIFICATION. ACCORDING TO THE FOURIER TRANSFORM INFRARED RADIATION RESULTS THE MATERIAL OBSERVED IS POLYTETRAFLUOROETHYLENE OR ¿TEFLON¿. THESE RESULTS WERE SHARED WITH VARIOUS ENGINEERS. THE COMPONENT IS NOT USED IN THE SYRINGE PRINTING OR ASSEMBLY PROCESS. ALSO, THE TWO SAMPLES RECEIVED DO NOT MATCH WITH THE FOREIGN MATTER SHOWN IN THE ONE PHOTO RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER CANNOT BE DETERMINED BASED ON EVALUATIONS PERFORMED. THE COMPONENT DEFINED (POLYTETRAFLUOROETHYLENE) IS NOT USED IN THE SYRINGE PRINTING OR ASSEMBLY 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 THE BD LUER LOK¿ SYRINGE HAD FOREIGN MATTER IN THE SYRINGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER LOK SYRINGE HAD FOREIGN MATTER IN THE SYRINGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8088529, MEDICAL DEVICE EXPIRATION DATE: 03/31/2023, DEVICE MANUFACTURE DATE: 04/18/2018. MEDICAL DEVICE LOT #: 8092640, MEDICAL DEVICE EXPIRATION DATE: 03/31/2023, DEVICE MANUFACTURE DATE: 05/03/2018. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 26 JUNE, 2018. MEDWATCH REPORT #: MW5078162. 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 THE BD LUER LOK¿ SYRINGE HAD FOREIGN MATTER IN THE SYRINGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547786 BD LUER LOK¿ SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903097020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other