BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 20GA 1.00IN HF Y

    MDR report key: 19430748 · Received May 30, 2024

    Report

    Report Number
    1710034-2024-00512
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 8, 2024
    Report Date
    July 16, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    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

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: 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 THE NEEDLE APPEARED TO BE COMPLETELY WITHDRAWN THROUGH THE TIP SHIELD SAFETY MECHANISM; THE TIP SHIELD REMAINED ATTACHED TO THE CATHETER ADAPTER, EVEN WHEN ATTEMPTS WERE MADE TO PULL THE TIP SHIELD FROM THE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

    (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED, NO APPARENT SI IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA 20GA 1.00IN HF Y SAFETY MECHANISM DOESN'T DISENGAGE FROM HUB. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION. THE IMPACT TO THE PATIENT IS THAT IF THE PATIENT IS A DIFFICULT STICK, THEY HAVE TO PULL THE CATHETER OUT AND POKE THE PATIENT AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275098 BD NEXIVA 20GA 1.00IN HF Y PERIPHERAL IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4030906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown