BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 20854972 · Received December 5, 2024

    Report

    Report Number
    1710034-2024-01433
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    October 17, 2024
    Report Date
    December 13, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835119
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383511 AND LOT NUMBER 4212075. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    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, (B)(6) WAS USED AS A PLACE HOLDER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SINGLE PORT NEEDLE CAME OUT OF HOUSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AHS MDIP REFERENCE NUMBER (ID): (B)(4). LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT. INCIDENT DETAILS: WHEN LOOSENING THE NEEDLE FROM THE CATHLON (STANDARD PRACTICE), THE NEEDLE FELL OUT OF THE NEXIVA. THIS HAPPENED TWICE. TYPICALLY, THE NEEDLE NEEDS TO BE MANUALLY PULLED OUT AND THE SAFETY WILL ENGAGE. WHO WAS AFFECTED? NO PERSON AFFECTED. (B)(6) THE ISSUE HAPPENED WHEN PREPPING THE IV, BEFORE TOUCHING THE PATIENT. TYPICALLY, THE NEEDLE NEEDS TO BE LOOSENED FROM THE CATHLON (SO IT CAN BE EASILY ADVANCED INTO THE VEIN). TO LOOSEN IT YOU PULL THE NEEDLE BACK AND THEN PUSH IT BACK IN. THIS IS WHAT I WAS IN THE PROCESS OF DOING WHEN THE NEEDLE FELL OUT ENTIRELY, AND THE SAFETY DID NOT ENGAGE. THE SAFETY WAS STILL ATTACHED TO THE CATHLON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2471735 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4212075 00382903835119

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown