BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 19455445 · Received June 3, 2024

    Report

    Report Number
    1710034-2024-00520
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    May 13, 2024
    Report Date
    July 16, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 4030906. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A VIDEO WAS PROVIDED TO AID IN OUR INVESTIGATION. THE VIDEO SHOWED A 20G NEXIVA IV CATHETER INSERTED IN THE PATIENT. THE NEEDLE APPEARED TO BE COMPLETELY WITHDRAWN THROUGH THE TIP SHIELD SAFETY MECHANISM; THE TIP SHIELD REMAINED ATTACHED TO THE CATHETER ADAPTER, EVEN WHEN ATTEMPTS WERE MADE TO PULL THE TIP SHIELD FROM THE ADAPTER. THE REPORTED NONCONFORMANCE HAS BEEN CONFIRMED. BASED ON THE PROVIDED VIDEO, OUR ENGINEERS HAVE ASSOCIATED THE ROOT CAUSE FOR THIS NONCONFORMANCE WITH THE MANUFACTURING PROCESS. MULTIPLE POTENTIAL CONTRIBUTING FACTORS CAN LEAD TO A DECOUPLING ISSUE, AND IDENTIFICATION OF THE MECHANISM OF FAILURE WILL NOT BE POSSIBLE WITHOUT THE ABILITY TO REVIEW THE PHYSICAL SAMPLE.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA- NEEDLE DID NOT DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEXIVA NEEDLE WOULDN'T SAFETY FROM THE CATHETER. THIS WAS ONLY NOTED IN PRE-OP AT KAISER MODETSO, NO OTHER UNITS HAVE REPORTED THE SAME ISSUE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659564 BD NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4030906 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown