BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML L/T SSU NRFIT WWS

    MDR report key: 20997689 · Received December 22, 2024

    Report

    Report Number
    1213809-2024-00986
    Event Type
    Malfunction
    Date Received
    December 22, 2024
    Date of Event
    November 26, 2024
    Report Date
    January 17, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    QEH
    UDI-DI
    00382904001742
    PMA / PMN Number
    K192538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EIGHTY-ONE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. SEVENTY-FIVE SAMPLES WERE FOUND WITH NO DEFECTS AND SIX SYRINGES WERE FOUND WITH NRFIT SCALE MARKINGS ON A LUER-LOK BARREL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSES FOR THE MIXED PRODUCT DEFECT COULD BE ASSOCIATED WITH FAILURE TO PROPERLY CONTAIN ANY PREVIOUSLY CONVEYED PRODUCT PRIOR TO THE NRFIT RUN AND INADEQUATE LINE CLEARANCE ON THE MARKING MACHINERY. SITUATION ANALYSIS AND CORRECTIVE AND PREVENTATIVE ACTIONS WERE INITIATED WITH MULTIPLE CORRECTIVE ACTIONS IDENTIFIED AND IMPLEMENTED. ADDITIONALLY, A CORRECTIVE ACTION OPENED UNDER INTERNAL EXCEPTION WAS TO BETTER CONTROL THE PROCESS RELATED TO CONVEYED RAW MATERIALS. THESE CHANGES WILL BE DOCUMENTED IN UPDATES TO THE PROCESS CONTROL FORMS AND APPLICABLE WORK INSTRUCTIONS. OPERATORS AND SUPERVISORS SIGNED OFF TO THE MACHINERY AND LINE CLEARANCE DOCUMENTATION WERE RE-EDUCATED TO THE DOCUMENTATION VIA INTERNAL SYSTEM. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1041220. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION 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.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    DESCRIPTION DETAILS: BEFORE USE: THERE IS A FAULT WITH THE 10ML SYRINGE NRFIT LOK LOT 1041220 REF (B)(4). WITHIN THE BATCH THERE ARE NORMAL LUER LOCK SYRINGES MIXED IN WITH THE NRFIT SYRINGES. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2623538 SYRINGE 10ML L/T SSU NRFIT WWS PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT QEH BECTON DICKINSON 1041220 00382904001742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown