BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE NRFIT¿ LOK

    MDR report key: 21023405 · Received December 26, 2024

    Report

    Report Number
    1213809-2024-00996
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    December 3, 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
    UK
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(6): SUPPLEMENTAL MDR - MIXED PRODUCT / LOTS. SIX HUNDRED AND NINETY-FIVE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. SIX HUNDRED SAMPLES WERE FOUND WITH NO DEFECTS AND NINETY-FIVE 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.

    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: WE HAVE HAD AN ISSUE DISCOVERED BY 2 SITES WHEN USING NRFIT SYRINGES AND DRAWING UP NEEDLE FOR SPINAL. THE SYRINGE WAS NOT COMPATIBLE WITH THE NEEDLE BUT COULD BE CONNECTED TO ORDINARY IV CANNULA. THIS IS AFFECTING BATCH (B)(4) WITH THE LOT NUMBER 1041220 CAN YOU PLEASE ADVISE DEAN AND I IF THE SUPPLIER WILL BE REPLACING OR CREDITING US FOR THE (B)(4) EA HE HAS MOVED INTO QUARANTINE LAST WEEK, AND WHAT WE NEED TO DO WITH THEIR QUARANTINED STOCK? ADDITIONAL INFORMATION PROVIDED: CUSTOMER RESPONSE RECEIVED INFORMATION REQUESTED IS BELOW; COMPANY: SPIRE HEALTHCARE NATIONAL DISTRIBUTION CENTRE COLLECTION POINT: GOODS IN/OUT STREET, NUMBER: (B)(6) BUILDING, FLOOR: NDC POSTAL CODE: (B)(6). COUNTRY: UK PLEASE ALSO PROVIDE US WITH THE PHONE NUMBER OF A PERSON WHO CAN BE CONTACTED BY THE CARRIER. CONTACT NAME: (B)(6). PHONE NUMBER: (B)(6) E-MAIL ADDRESS: [email protected].

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995537 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