BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20GA 1.00IN HF Y W/ CAP

    MDR report key: 9981955 · Received April 21, 2020

    Report

    Report Number
    1710034-2020-00270
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    April 1, 2020
    Report Date
    June 15, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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. A ROOT CAUSE COULD NOT BE DETERMINED AND THE COMPLAINT IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER USE THE NEXIVA 20GA 1.00IN HF Y W/ CAP HAD LEAKAGE AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CANNULA WASN¿T SECURE AND BLOOD WENT EVERYWHERE ON TWO OCCASIONS."

    Additional Manufacturer Narrative · 1

    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 AFTER USE THE NEXIVA 20GA 1.00IN HF Y W/ CAP HAD LEAKAGE AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CANNULA WASN'T SECURE AND BLOOD WENT EVERYWHERE ON TWO OCCASIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445003 NEXIVA 20GA 1.00IN HF Y W/ CAP INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9295610

    Patients

    Seq Age Sex Outcome Treatment
    1 Other