BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20 GA X 1 IN SINGLE PORT

    MDR report key: 9635896 · Received January 28, 2020

    Report

    Report Number
    1710034-2020-00031
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    January 7, 2020
    Report Date
    February 28, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835165
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEXIVA 20 GA X 1 IN SINGLE PORT EXPERIENCED HAVING THE SAFETY MECHANISM UNABLE TO DISENGAGE FROM THE CATHETER/STUCK AT HUB. PRODUCT DEFECT WAS NOTED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383516 BATCH NO: 9252054 IT WAS REPORTED THAT THE NEEDLE RUBBED AND SCRAPPED DURING RETRACTION AND ONLY PARTIALLY RETRACTED. EVENT DESCRIPTION PER STATES: BD NEXIVA IV OPENED AT BEDSIDE WAS NOT RETRACTABLE AND RUBBED AND SCRAPED AS THE INSERTER NEEDLE WAS RETRACTED SLIGHTLY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEXIVA 20 GA X 1 IN SINGLE PORT EXPERIENCED HAVING THE SAFETY MECHANISM UNABLE TO DISENGAGE FROM THE CATHETER/STUCK AT HUB. PRODUCT DEFECT WAS NOTED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383516, BATCH NO: 9252054. IT WAS REPORTED THAT THE NEEDLE RUBBED AND SCRAPPED DURING RETRACTION AND ONLY PARTIALLY RETRACTED. EVENT DESCRIPTION PER STATES: BD NEXIVA IV OPENED AT BEDSIDE WAS NOT RETRACTABLE AND RUBBED AND SCRAPED AS THE INSERTER NEEDLE WAS RETRACTED SLIGHTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103300 NEXIVA 20 GA X 1 IN SINGLE PORT INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383516 9252054 30382903835165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other