BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM

    MDR report key: 11268814 · Received February 2, 2021

    Report

    Report Number
    1710034-2021-00072
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Date of Event
    January 7, 2021
    Report Date
    January 21, 2021
    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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON (DATE) VIA MEDWATCH # (B)(4). (B)(4). INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. 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. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY. INVESTIGATION CONCLUSION: THE DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383536, BATCH NO: 9233236. IT WAS REPORTED THAT WHEN IN USE THE IV CATHETER LEAKED. MANUFACTURER WAS CONTACTED BY HOSPITAL TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165300 BD NEXIVA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9233236 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1