BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 17446992 · Received August 2, 2023

    Report

    Report Number
    1710034-2023-00861
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 15, 2023
    Report Date
    September 21, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 13-SEP-2023. H.6. INVESTIGATION SUMMARY: BD RECEIVED A 24 GAUGE NEXIVA CATHETER ASSEMBLY FROM LOT 2182098 FOR EVALUATION AND A VIDEO OF THE REPORTED DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED BLOOD INDICATING THAT THE DEVICE HAD BEEN USED. NEXT, THE ENGINEER PERFORMED A LEAK TEST AND OBSERVED LEAKAGE UNDER THE NOSE OF THE CATHETER ADAPTER. THE DEVICE WAS THEN DISASSEMBLED AND EVALUATED UNDER A MICROSCOPE. DURING INSPECTION, THE ENGINEER FOUND THAT THE CATHETER HAD A HOLE AT THE TIP OF THE SWAGE PIN. THE PROVIDED VIDEO SHOWED SIMILAR FINDINGS TO THE LEAKAGE TEST. THEREFORE, BASED OFF THE VISUAL/MICROSCOPIC INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THE DAMAGE TO THE SWAGE PIN OCCURRED DURING THE ASSEMBLY PROCESS DUE TO A MISALIGNMENT BETWEEN THE SWAGE PIN AND THE CATHETER. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A NOTIFICATION HAS BEEN ISSUED TO ALL MANUFACTURING PERSONNEL TO RAISE AWARENESS OF THIS ISSUE AND PREVENT RECURRENCE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THERE IS LEAKAGE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: VERBATIM: DURING USE. AFTER INSERTION, DURING FLUSHING, LEAKAGE WAS REPORTED FROM JUNCTION POINT. AFTER INSERTION, DURING FLUSHING THERE WAS LEAKAGE FROM JUNCTION POINT LEADS TO REMOVAL OF CANNULA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THERE IS LEAKAGE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: VERBATIM: DURING USE. AFTER INSERTION, DURING FLUSHING, LEAKAGE WAS REPORTED FROM JUNCTION POINT. AFTER INSERTION, DURING FLUSHING THERE WAS LEAKAGE FROM JUNCTION POINT LEADS TO REMOVAL OF CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280756 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2182098

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown