BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM

    MDR report key: 10258916 · Received July 10, 2020

    Report

    Report Number
    1710034-2020-00440
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    June 19, 2020
    Report Date
    September 1, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, D.10 RETURNED TO MANUFACTURER ON: 2020-08-13. INVESTIGATION SUMMARY BD RECEIVED AN UNUSED 18 GAUGE NEXIVA UNIT FROM LOT 9221847 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED NO PHYSICAL/MECHANICAL DAMAGE TO THE RETURNED UNIT. A REACTION TO THE PRODUCT COULD RESULT FROM CONTAMINATED UNIT. PER THE DHR REVIEW IT WAS NOTED THAT THIS UNIT WAS BUILT, PACKAGED AND STERILIZED PER SPECIFICATIONS AND WITHIN COMPLIANCE. THE DEVICE ALSO APPEARED TO BE UNUSED. BASED OFF THE VISUAL INSPECTION AND DHR REVIEW THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECT WAS FOUND DURING EVALUATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. H3 OTHER TEXT : SEE H.10.

    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 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REDNESS OCCURS AT THE PUNCTURE SITE THROUGH THE ENTIRE LENGHT OF THE CATHETER. MOREOVER, AREA OUTSIDE OF THE FIXATIVE IS ALSO RED WHAT IS SUPPORTED BY THE IMAGE FROM THE ATTACHMENT. FUTHERMORE, 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, ADIMINISTRATION 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 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REDNESS OCCURS AT THE PUNCTURE SITE THROUGH THE ENTIRE LENGHT 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
    722778 BD NEXIVA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9221847

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention