BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8061932 · Received November 12, 2018

    Report

    Report Number
    1710034-2018-00840
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Date of Event
    November 6, 2018
    Report Date
    February 15, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DHR WAS PERFORMED AND QN (B)(4) (KINKED TUBING) AND QN (B)(4) (MISSING PRINT-PKG) WERE INITIATED DURING PRODUCTION. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTION WERE APPLIED PER QUALITY PLANS. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. ONE PHOTO SUBMITTED FOR REVIEW. BASED ON THE EVALUATION OF THE SUBMITTED PHOTO THE DEFECT SEPARATION INSERTER FROM TUBING WAS CONFIRMED. THE PHOTO DISPLAYED THE WINGED ADAPTER WAS SEPARATED FROM THE EXTENSION SET. ALTHOUGH THE UNIT WAS NOT RETURNED FOR EVALUATION; GIVEN THE TREND IDENTIFIED BY THE QDA AND PHOTO FOR THIS DEFECT, IT IS LIKELY THAT THE FAILURE WAS DUE TO AN INSUFFICIENT AMOUNT OF ADHESIVE IN THE EXTENSION TUBING/ ADAPTER JOINT. THIS DEFECT SS CREATED AT THE NEW ZONE 8 ADHESIVE DISPENSE STATION. WHEN THE ADHESIVE DISPENSES TIPS BECOME MISALIGNED, ADHESIVE IS NOT DISPENSED IN THE PROPER LOCATION LEADING TO AN INSUFFICIENT AMOUNT OF ADHESIVE IN THE TUBING/ADAPTER PORT JOINT. THIS FAILURE MODE OF THE PROCESS WAS INTRODUCED BY THE NEW STATION DESIGN, AND THE 100% ADHESIVE PRESENCE VISION SYSTEM WAS NOT CAPABLE OF DETECTING THESE FAILURES. THE TREND ANALYSIS IDENTIFIED BY THE QDA FOR THIS DEFECT, DISCOVERED THE FAILURE WAS DUE TO AN INSUFFICIENT AMOUNT OF ADHESIVE IN THE EXTENSION TUBING/ ADAPTER JOINT. THE MANUFACTURING DEPARTMENT IDENTIFIED THE ISSUE AND TOOK IMMEDIATE CORRECTIVE ACTION ON 11 SEP 2018 BY UPGRADING THE VISION SYSTEM ON BOTH PRODUCTION LINES TO BE ABLE TO DETECT ADHESIVE THAT WAS NOT IN THE CORRECT LOCATION. HOLDERS FOR THE ADHESIVE DISPENSE TIPS WERE ADDED TO THE MACHINE ON 26 SEP 2018 TO BETTER PROTECT THE TIPS FROM DAMAGE AND BECOMING MISALIGNED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM BROKE APART DURING USE. A SMALL PORTION OF THE BROKEN CATHETER WAS STUCK IN PATIENT, HOWEVER NO MEDICAL INTERVENTION WAS REPORTED FOR ITS REMOVAL. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED THAT A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM BROKE APART DURING USE. A SMALL PORTION OF THE BROKEN CATHETER WAS STUCK IN PATIENT, HOWEVER NO MEDICAL INTERVENTION WAS REPORTED FOR ITS REMOVAL. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901575 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8235504 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 Other