BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8473399 · Received April 2, 2019

    Report

    Report Number
    1710034-2019-00358
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    January 17, 2019
    Report Date
    April 23, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835110
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: H.6. INVESTIGATION: DHR REVIEW: ALL CHALLENGES, SET UP AND IN-PROCESS SAMPLES WERE PREFORMED ACCORDING TO THE QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. THERE WERE 5 NON-RELATED QNS INITIATED FOR THIS LOT. ALTHOUGH THE UNIT WAS NOT RETURNED FOR EVALUATION; GIVEN THE TREND IDENTIFIED BY THE QDA FOR THIS DEFECT AND LOT NUMBER, IT IS LIKELY THAT THE FAILURE WAS DUE TO AN INSUFFICIENT AMOUNT OF ADHESIVE IN THE EXTENSION TUBING/ ADAPTER JOINT. THE DEVICE FAILURE WAS MOST LIKELY DUE TO AN INSUFFICIENT AMOUNT OF ADHESIVE IN THE EXTENSION TUBING/ ADAPTER JOINT. 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, CAPA# 684099, 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 (SEE PROTOCOLS 19217 AND 19223). 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 (SEE CHANGE CCSCM-686).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THE EXTENSION TUBING DISCONNECTED FROM THE HUB OF THE IV NEEDLE. MATERIAL NO. 383511 BATCH NO. 8235512 THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT PRESENTED TO THE FACILITY FOR AN IV INFUSION. AFTER THE IV WAS STARTED, STAFF REMOVED THE CAP POSITIONED AT THE END OF THE EXTENSION TUBING TO CONNECT THE EXTENSION TUBING TO THE IV LINE. AT THIS TIME, THE EXTENSION TUBING DISCONNECTED FROM THE HUB OF THE IV NEEDLE. VERY LITTLE TENSION WAS PLACED ON THE EXTENSION TUBING DURING THE ATTEMPT TO REMOVE THE CAP. THE PATIENT HAD TO BE RESTARTED."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: DHR REVIEW: ALL CHALLENGES, SET UP AND IN-PROCESS SAMPLES WERE PREFORMED ACCORDING TO THE QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. THERE WERE 5 NON-RELATED QNS INITIATED FOR THIS LOT. ALTHOUGH THE UNIT WAS NOT RETURNED FOR EVALUATION; GIVEN THE TREND IDENTIFIED BY THE (B)(4) FOR THIS DEFECT AND LOT NUMBER, IT IS LIKELY THAT THE FAILURE WAS DUE TO AN INSUFFICIENT AMOUNT OF ADHESIVE IN THE EXTENSION TUBING/ ADAPTER JOINT. THE DEVICE FAILURE WAS MOST LIKELY DUE TO AN INSUFFICIENT AMOUNT OF ADHESIVE IN THE EXTENSION TUBING/ ADAPTER JOINT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THE EXTENSION TUBING DISCONNECTED FROM THE HUB OF THE IV NEEDLE. MATERIAL NO. 383511, BATCH NO. 8235512. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT PRESENTED TO THE FACILITY FOR AN IV INFUSION. AFTER THE IV WAS STARTED, STAFF REMOVED THE CAP POSITIONED AT THE END OF THE EXTENSION TUBING TO CONNECT THE EXTENSION TUBING TO THE IV LINE. AT THIS TIME, THE EXTENSION TUBING DISCONNECTED FROM THE HUB OF THE IV NEEDLE. VERY LITTLE TENSION WAS PLACED ON THE EXTENSION TUBING DURING THE ATTEMPT TO REMOVE THE CAP. THE PATIENT HAD TO BE RESTARTED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THE EXTENSION TUBING DISCONNECTED FROM THE HUB OF THE IV NEEDLE. MATERIAL NO. 383511, BATCH NO. 8235512. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT PRESENTED TO THE FACILITY FOR AN IV INFUSION. AFTER THE IV WAS STARTED, STAFF REMOVED THE CAP POSITIONED AT THE END OF THE EXTENSION TUBING TO CONNECT THE EXTENSION TUBING TO THE IV LINE. AT THIS TIME, THE EXTENSION TUBING DISCONNECTED FROM THE HUB OF THE IV NEEDLE. VERY LITTLE TENSION WAS PLACED ON THE EXTENSION TUBING DURING THE ATTEMPT TO REMOVE THE CAP. THE PATIENT HAD TO BE RESTARTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265174 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8235512 30382903835110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other