BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L&ERESEARCH-NEXIVA-2024

    MDR report key: 19226620 · Received May 1, 2024

    Report

    Report Number
    1710034-2024-00380
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 4, 2024
    Report Date
    April 11, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE CONFIRMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    DURING A VOICE OF CUSTOMER STUDY THE FOLLOWING FEEDBACK WAS RECEIVED: CLINICIAN (RADIOLOGIC TECHNICIAN) STATED THAT HE'S SEEN TECHS ACCIDENTALLY PULL THE WHOLE CATHETER OUT WHEN TRYING TO REMOVE THE NEEDLE WITH A NEXIVA PRODUCT FAMILY DEVICE AND THAT IT HAPPENS WHEN THEY TRY TO REMOVE THE NEEDLE TOO QUICKLY OR IF THEY DON'T USE A TWO HANDED TECHNIQUE. COMMENT OBSERVED DURING A VOICE OF CUSTOMER RESEARCH STUDY. COMMENT WAS GENERAL IN NATURE. CLINICIAN WAS NOT REFERENCING A SPECIFIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879976 L&ERESEARCH-NEXIVA-2024 PERIPHERAL IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown