BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE NRFIT¿ LOK

    MDR report key: 20668584 · Received November 12, 2024

    Report

    Report Number
    1213809-2024-00829
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 15, 2024
    Report Date
    January 17, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    QEH
    UDI-DI
    00382904001742
    PMA / PMN Number
    K192538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THREE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL 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

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE NRFIT¿ LOK HAD MIXED PRODUCT /LOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER REPORTS IN THE NATIONAL NETWORK FOR NR-FIT'S INTRODUCTION, THERE WAS INFORMATION THAT SYRINGES MARKED NR-FIT COULD HAVE A REGULAR LUER CONNECTION. THE INFORMATION WAS SENT OUT TO THE UNITS WITH US THAT ORDERED THE ITEM IN QUESTION AND WE HAVE THUS RECEIVED, AND WISH TO COMPLAIN ABOUT THE ABOVE ITEM WITH LOT NO. 1041220. IT IS THE MANUFACTURING PHARMACY AT THE HOSPITAL THAT HAS GONE THROUGH ITS ARTICLES AND FOUND 13 MISSING SYRINGES IN A BOX OF NRFIT SYRINGES. I HAVE ASKED THEM TO SEND ME THE SYRINGES CONCERNED AND WILL RECEIVE THEM THIS WEEK AND CAN THEN SEND THEM TO YOU SYRINGES MARKED AND PACKAGED AS BEING NRFIT¿ BUT WITH THE LUER CONNECTOR!!! ADDITIONAL INFORMATION PROVIDED: - COULD YOU PLEASE CONFIRM THE CATALOGUE NUMBER (400174) OF THE DEFECTIVE PRODUCT? = CORRECT. - COULD YOU PLEASE PROVIDE A DATE OF EVENT? = 15/10-24. - HAS THERE BEEN ANY PATIENT IMPACT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE OF TREATMENT REQUIRED)? = NO. - HAVE ANY OTHER ACTIONS BEEN TAKEN? = NOT FROM US. - PLEASE CONFIRM IF THE USED SAMPLES ARE CONTAMINATED WITH BLOOD OR CYTOTOXIC MEDICATION. = NOT CONTAMINATED. - IF YOU HAVE RETAINED A SAMPLE FOR INVESTIGATION, PLEASE PROVIDE US WITH THE BELOW PICK-UP DETAILS. = AS SOON AS I GET THEM I WILL DO THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975925 BD SYRINGE NRFIT¿ LOK PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT QEH BECTON DICKINSON MEDICAL SYSTEMS 1041220 00382904001742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown