BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8926401 · Received August 23, 2019

    Report

    Report Number
    1710034-2019-00919
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    July 31, 2019
    Report Date
    September 23, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED ONE USED NEXIVA 20GA UNIT IN AN OPENED PACKAGE FROM MATERIAL NUMBER 383536, LOT NUMBER 9122557. DHR REVIEW WAS PERFORMED ON LOT NUMBER 9122557 THE NEEDLE SET WAS RETRACTED, AND THE WING ADAPTER WAS STILL ATTACHED TO THE TIP SHIELD THE V-CLIP WAS NOT INSTALLED IN THE CORRECTLY POSITION, WITH THE FLAP HOLDING THE CATHETER ADAPTER IN PLACE. THE WING ADAPTER WAS A LITTLE DIFFICULT TO REMOVE FROM THE TIP SHIELD; BUT IT WAS REMOVED. OBSERVED A SMALL PROTRUSION ON THE RIDGE INSIDE OF THE TIP SHIELD. THE ROOT CAUSE WOULD BE MOLDING. THE DEFECT TIP ADHESION WAS NOT IDENTIFIED OR CONFIRMED WITH THE RETURNED UNIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SAFETY MECHANISM ISSUE OCCURRED WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "HAVING ISSUES WITH THE BD NEXIVA, 383536 ¿ 20GA X 1.00IN CLOSED IV CATHETER SYSTEM. LOT NUMBER OF CURRENT ISSUE IS 9122557. THE SAFETY NEEDLE WOULD NOT RELEASE FROM THE IV CATHETER."

    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 SAFETY MECHANISM ISSUE OCCURRED WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "HAVING ISSUES WITH THE BD NEXIVA, 383536 ¿ 20GA X 1.00IN CLOSED IV CATHETER SYSTEM. LOT NUMBER OF CURRENT ISSUE IS 9122557. THE SAFETY NEEDLE WOULD NOT RELEASE FROM THE IV CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722149 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9122557 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other