BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8725560 · Received June 23, 2019

    Report

    Report Number
    1710034-2019-00656
    Event Type
    Malfunction
    Date Received
    June 23, 2019
    Date of Event
    June 3, 2019
    Report Date
    September 16, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835165
    PMA / PMN Number
    K183399
    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: OUR QUALITY ENGINEER INSPECTED THE SAMPLES PROVIDED. BD RECEIVED 160 NEXIVA REPRESENTATIVE UNITS IN SEALED PACKAGES AND INSIDE DISPENSERS FROM LOT NUMBER 8214832. THE DISPENSERS WERE WITHIN A CARDBOARD BOX. ALL CONTENTS WITHIN WERE INTACT. THROUGH THE VISUAL/MICROSCOPIC EVALUATION, THE EXTENSION TUBINGS WERE MANUALLY PULLED ON ALL OF THE UNITS RECEIVED WHERE NO DISCONNECTIONS OCCURRED ON ANY OF THE UNITS RECEIVED. THERE WAS NO PHYSICAL-MECHANICAL DAMAGE FOUND ON ANY OF THE AREAS OF THE UNITS RECEIVED. THE RETURNED REPRESENTATIVE UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN YOUR REPORT. DURING DHR REVIEW NO REJECT ACTIVITY ASSOCIATED WITH THE LOT NUMBER PROVIDED WAS FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEFECTIVE TUBING WAS FOUND WITH BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "TUBING NOT WORKING PROPERLY". 7 OCCURRENCES WERE REPORTED DURING USE THE DATE/TIME AND PATIENT INFORMATION WERE NOT GIVEN.

    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 DEFECTIVE TUBING WAS FOUND WITH BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "TUBING NOT WORKING PROPERLY". 7 OCCURRENCES WERE REPORTED DURING USE THE DATE/TIME AND PATIENT INFORMATION WERE NOT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519083 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8214832 30382903835165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other