BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SP WITH MAXZERO

    MDR report key: 20440467 · Received October 14, 2024

    Report

    Report Number
    1710034-2024-01142
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    September 23, 2024
    Report Date
    December 2, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835577
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT THAT THE NEEDLE WAS DIFFICULT TO REMOVE WAS CONFIRMED AND THE CAUSE APPEARED TO BE SUPPLIER RELATED. REPRESENTATIVE 20G NEXIVA UNITS FROM LOT# 4152107 WERE PROVIDED FOR INVESTIGATION. TWO SAMPLES WERE FOUND WITH RESISTANCE BETWEEN THE NEEDLE AND SAFETY MECHANISM. THE OUTSIDE DIAMETER OF THE NEEDLE WAS WITHIN SPEC. THE INSIDE DIAMETER OF THE SAFETY MECHANISM COMPONENT WAS BELOW SPECIFICATION, WHICH CREATED FRICTION AS THE NEEDLE WITHDRAWN THROUGH THE SAFETY MECHANISM. THE APPROPRIATE PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA 20 GA X 1.25IN SP WITH MAXZERO DIFFICULT TO DISENGAGE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ATTEMPTING TO REMOVE THE NEEDLE, THEY TEND TO GET STUCK AND ARE DIFFICULT TO EXTRACT. INJURIES OR ADVERSE EVENT: NO. (B)(6) 2024. THIS HAS HAPPENED THROUGHOUT THE MONTH OF SEPTEMBER; I DO NOT HAVE EXACT DATES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716431 BD NEXIVA SP WITH MAXZERO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4152107 00382903835577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown