BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8016823 · Received October 29, 2018

    Report

    Report Number
    1710034-2018-00767
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 9, 2018
    Report Date
    December 11, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835165
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED ONE USED NEXIVA 20 GA UNIT WITH AN OPENED PACKAGE FROM THE LOT NUMBER 8113784. THE UNIT CONSISTED OF THE CATHETER ADAPTER/EXTENSION SET ASSEMBLY. THE NEEDLE SET ASSEMBLY WAS NOT RETURNED FOR EVALUATION. TWO PHOTOS WERE SUBMITTED FOR REVIEW. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF SEPARATION INSERTER FROM TUBING WITH LOT #8113784 REGARDING ITEM #383516. DHR REVIEW WAS PERFORMED ON LOT NUMBER 8113784. THE LOT NUMBER WAS BUILT/PACKAGED ON NFA LINE #1 FROM 26APRIL2018 THRU 27APRIL2018. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. UNIT ANALYSIS: A VERY SMALL AMOUNT OF BODILY FLUIDS IN THE CATHETER TUBING. THE EXTENSION TUBING WAS SEPARATED FROM THE CLEAR PORT OF THE CATHETER ADAPTER. NO ADHESIVE WAS FOUND ON THE EXTENSION TUBING OR AROUND OR IN THE CLEAR PORT OF THE CATHETER ADAPTER PHOTO ANALYSIS: PHOTO ONE DISPLAYED THE PAPER TOP WEB WITH THE BD LOGO, REF NO., DESCRIPTION, LOT NUMBER AND THE EXPIRATION DATE. PHOTO TWO DISPLAYED THE EXTENSION TUBING SEPARATED FROM THE CATHETER ADAPTER. MANUFACTURING ¿ THIS DEFECT IS CREATED AT THE NEW ZONE 8 ADHESIVE DISPENSE STATION. WHEN THE ADHESIVE DISPENSE 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 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. CAPA 684099 HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE. EURA (END USER RISK ANALYSIS) STATES THAT THE EFFECT OF MINOR LEAKAGE HAS A LIMITED SEVERITY WITH RANKING S2. THE END USER EFFECT OF MINOR LEAKAGE HAS OCCASIONAL OCCURRENCE OF O3 ( =100 IPM) FOR THE FAILURE MODE OF EXTENSION TUBING DETACHED FROM CATHETER ADAPTER. WITH LIMITED SEVERITY AND OCCASIONAL OCCURRENCE, THE RISK TO THE END USER IS ACCEPTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM SEPARATED AT THE HUB DURING USE AND BLOOD LEAKED EVERYWHERE. THERE WAS NO REPORT OF EXPOSURE TO THE MUCOSAL MEMBRANE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM SEPARATED AT THE HUB DURING USE AND BLOOD LEAKED EVERYWHERE. THERE WAS NO REPORT OF EXPOSURE TO THE MUCOSAL MEMBRANE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856312 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8113784 30382903835165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other