BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 20158188 · Received September 6, 2024

    Report

    Report Number
    1710034-2024-00989
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 14, 2024
    Report Date
    October 3, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835324
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    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

    THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE DISENGAGEMENT DIFFICULT WITH LOT 3180988 REGARDING ITEM #383532. THE DHR FOR LOT 3180988 HAS BEEN REVIEWED. LOT NUMBER 3180988 WAS BUILT AND PACKAGED ON NFA 3 FROM 15JUL2023 THROUGH 18JUL2023 FOR A QUANTITY OF (B)(4). NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA PROBLEM WITH DISENGAGING THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MALFUNCTION IN RETRACTING THE NEEDLE. ADDITIONAL INFO: 1) THERE WAS NO ADVERSE EVENT OR SERIOUS INJURY TO THE PATIENT. 2) LOT NUMBER FOR THE PRODUCT IS 3180988. 3) THIS IS THE FIRST OCCURRENCE ON THIS PRODUCT THAT HAS BEEN BROUGHT TO MY ATTENTION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887899 BD NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3180988 00382903835324

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown