BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM

    MDR report key: 10258917 · Received July 10, 2020

    Report

    Report Number
    1710034-2020-00439
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    June 19, 2020
    Report Date
    August 19, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6.INVESTIGATION SUMMARY A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH THREE PHOTOS OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 9221847, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. THE LOT WAS DOCUMENTED AS BEING PROPERLY STERILIZED WITH NO ISSUES OBSERVED. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTOS AND OBSERVED A 20 GAUGE NEXIVA UNIT IN USE WITH A TRANSPARENT DRESSING PLACED OVER THE INSERTION SITE. THERE ARE TRACES OF MEDIA PRESENT AT THE INSERTION SITE AND DOWN A PORTION OF THE EXTENSION LINE INDICATING A SUCCESSFUL ACTIVATION. HOWEVER, THERE IS ALSO VISIBLE REDNESS AT THE INSERTION SITE THAT RUNS PARTIALLY UP THE ARM. BASED OFF THE PROVIDED PHOTOS THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR TESTING. IT WAS ALSO REPORTED THAT EXTRAVASATIONS WERE OBSERVED AND MONITORED DUE TO THE INSERTION. THIS COULD BE A CONTRIBUTING FACTOR AS WELL. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT REDNESS OCCURRED AT THE PUNCTURE SITE THROUGH THE ENTIRE LENGTH OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM, CAUSING EXTRAVASATIONS THAT WERE MAINLY NOTICED ON THE THIRD DAY OF PLACEMENT. AN "X-RAY, CT SCAN, MAGNET, GASTROSCOPY, AND ERCP" WERE PERFORMED, ANTIBIOTICS GIVEN, AND THE CATHETER WAS REPLACED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REDNESS OCCURS AT THE PUNCTURE SITE THROUGH THE ENTIRE LENGTH OF THE CATHETER. MOREOVER, AREA OUTSIDE OF THE FIXATIVE IS ALSO RED WHAT IS SUPPORTED BY THE IMAGE FROM THE ATTACHMENT. FURTHERMORE, THEY ALSO NOTICED AND MONITORED EXTRAVASATIONS DUE TO THE INSERTION OF CATHETER. THESE SITUATIONS MOSTLY ARISES ON THIRD DAY OF THE CATHETER INSERTION WHICH FORCE NURSES TO REPLACE THE CATHETER." "X-RAY, CT SCAN, MAGNET, GASTROSCOPY, ERCP, ADMINISTRATION OF ANTIBIOTICS."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REDNESS OCCURRED AT THE PUNCTURE SITE THROUGH THE ENTIRE LENGTH OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM, CAUSING EXTRAVASATIONS THAT WERE MAINLY NOTICED ON THE THIRD DAY OF PLACEMENT. AN "X-RAY, CT SCAN, MAGNET, GASTROSCOPY, AND ERCP" WERE PERFORMED, ANTIBIOTICS GIVEN, AND THE CATHETER WAS REPLACED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REDNESS OCCURS AT THE PUNCTURE SITE THROUGH THE ENTIRE LENGTH OF THE CATHETER. MOREOVER, AREA OUTSIDE OF THE FIXATIVE IS ALSO RED WHAT IS SUPPORTED BY THE IMAGE. FURTHERMORE, THEY ALSO NOTICED AND MONITORED EXTRAVASATIONS DUE TO THE INSERTION OF CATHETER. THESE SITUATIONS MOSTLY ARISES ON THIRD DAY OF THE CATHETER INSERTION WHICH FORCE NURSES TO REPLACE THE CATHETER." "X-RAY, CT SCAN, MAGNET, GASTROSCOPY, ERCP, ADMINISTRATION OF ANTIBIOTICS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722779 BD NEXIVA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9284508

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention