BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 10448159 · Received August 25, 2020

    Report

    Report Number
    1213809-2020-00567
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 6, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8182732. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30. DEVICE MANUFACTURE DATE: 2018-07-01. MEDICAL DEVICE LOT #: 9070658. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-03-11. MEDICAL DEVICE LOT #: 9234101. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-08-22. (B)(4). INVESTIGATION SUMMARY: THREE PHOTOS EACH DISPLAYING ONE LOOSE 5ML SYRINGE WERE RECEIVED AND EVALUATED. TWO OF THE SYRINGES CONTAINED APPROXIMATELY 3ML OF CLEAR LIQUID AND HAD ORANGE TIP CAPS ATTACHED. BOTH SYRINGES WERE OBSERVED TO CONTAIN A SMALL YELLOW CYLINDRICAL PARTICLE IN THE FLUID PATH NEAR THE STOPPER. THE COMPOSITION OF THE PARTICLE COULD NOT BE DETERMINED FROM THE PHOTO AND THE TWO SYRINGES WERE MANIPULATED. THE DEFECT COULD NOT BE CONFIRMED. ONE SYRINGE APPEARED TO BE UNUSED AND CONTAINED A SMALL BROWN EMBEDDED FOREIGN MATTER PARTICLE OUTSIDE THE GRAD LINES NEAR THE 5ML MARKING. THE PARTICLE APPEARED TO BE BURNT PLASTIC AND WAS LARGER THAN LEVEL 3 IN SIZE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCHES 9234101, 8182732, AND 9070658 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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. ROOT CAUSE DESCRIPTION: THE POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER IN THE FLUID PATH IS UNCONFIRMED. THE SYRINGES DISPLAYING PARTICLES IN THE FLUID PATH WERE MANIPULATED AND THE COMPOSITION OF THE PARTICLES COULD NOT BE DETERMINED FROM THE PHOTOS. THE POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FM 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. RATIONALE: NO CAPA REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS DISCOVERED IN SYRINGE WITH A BD SYRINGE 5ML LL BNS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "I WANTED TO REPORT THE RECEIPT OF TWO COMPLAINTS FOR THE PRESENCE OF A PARTICLE. SAMPLES ARE NOT CURRENTLY AVAILABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916651 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other