BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 24 GA X 3/4 IN SINGLE PORT

    MDR report key: 19426485 · Received May 30, 2024

    Report

    Report Number
    1710034-2024-00508
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    April 3, 2024
    Report Date
    June 11, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383511 AND LOT NUMBER 3040438. 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. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. 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

    IT WAS REPORTED THAT BD NEXIVA 24 GA X 3/4 IN SINGLE PORT NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN INSERTING A BD NEXIA 24G IV INTO THE PATIENTS LEFT ACF THE NEEDLE WAS BROKE THROUGH THE IV CATHETER AFTER INSERTION. IMMEDIATELY REMOVED AND ALL PARTS ACCOUNTED FOR. NO HARM TO PATIENT, APOLOGY MADE, PHOTO OF PRODUCT MALFUNCTION EMAILED TO NURSING MANAGER TO REPORT TO QUALITY AND RISK. DEVICE_NAME_AS_REPORTED NEXIA 24G IV.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422437 BD NEXIVA 24 GA X 3/4 IN SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3040438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown