BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    50 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE

    MDR report key: 13840637 · Received March 21, 2022

    Report

    Report Number
    1911916-2022-00145
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    March 4, 2022
    Report Date
    June 17, 2024
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS FOUND THAT FOREIGN SUBSTANCES OCCURRED ON THE SURFACE OF THE SYRINGE PLUNGER BEFORE USING THE PRODUCT DURING ROOM TEMPERATURE STORAGE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND ONE PHOTO WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE SAMPLE HAS PLASTIC PARTICLES AT THE BOTTOM OF THE SYRINGE. THE INNER WALL OF THE SYRINGE BARREL HAS SOME MARKS AND THE RETAINING RING IS DAMAGED. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. THIS DEFECT COULD OCCUR DURING THE MOLDING PROCESS IF THE BARREL WAS NOT EJECTED FROM THE MOLD DURING THE FIRST ATTEMPT. ADDITIONAL ATTEMPTS OF THE PART BEING EJECTED FROM THE MOLDING TOOL INDUCES THE WHITE FOREIGN MATTER. THIS IS COMING FROM THE INNER WALL OF THE SYRINGE BARREL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 1112044. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE MOLDING PROCESS WAS PERFORMED. THE MOLDING SETTINGS WERE CORRECT AND THE PARTS WERE BEING EJECTED WITHOUT ISSUE. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING 50 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS FOUND THAT FOREIGN SUBSTANCES OCCURRED ON THE SURFACE OF THE SYRINGE PLUNGER BEFORE USING THE PRODUCT DURING ROOM TEMPERATURE STORAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25662 50 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 1112044 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown