BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 22012820 · Received May 13, 2025

    Report

    Report Number
    1710034-2025-00832
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 29, 2025
    Report Date
    May 27, 2025
    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
    MO, 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383536 AND LOT NUMBER 4242208. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA LEAKED AT THE PIGTAIL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I RECEIVED A MESSAGE THIS MORNING THAT ONE OF THE CATH IVS LEAKED AT THE PIGTAIL WHEN A NURSE WAS FLUSHING THE SYSTEM THIS MORNING. UNABLE TO USE THE IV, HAVE TO PULL OUT OF PATIENT. WASTING TIME FOR THE CLINICIAN TO START ANOTHER IV. ANOTHER STICK FOR THE PATIENT TO START A GOOD IV.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369167 BD NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4242208 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown