BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MIVI Q CATHETER

    MDR report key: 16174809 · Received January 16, 2023

    Report

    Report Number
    3011410509-2023-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2023
    Date of Event
    December 15, 2022
    Report Date
    January 13, 2023
    Manufacturer
    MIVI NEUROSCIENCE, INC.
    Product Code
    DQY
    PMA / PMN Number
    K192558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UPON OPENING A Q6 BOX, THE HOSPITAL REPORTED THE POUCH WAS PARTIALLY "UNSEALED". AN INVESTIGATION DETERMINED AN INCOMPLETE OR WEAK SEAL DID NOT MEET SPECIFICATIONS FOR THIS DEVICE. NO PATIENTS WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224053 MIVI Q CATHETER CATHETER DQY MIVI NEUROSCIENCE, INC. Q6-69145-E M21090005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown