BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRAFLOW

    MDR report key: 11869746 · Received May 21, 2021

    Report

    Report Number
    MW5101484
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    May 15, 2021
    Report Date
    May 19, 2021
    Manufacturer
    IRRAS USA, INC
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    AFTER PATIENT WAS BATHED IT WAS NOTED THE LRRAFLAW CATHETER HAD BROKEN OFF THE MALE CONNECTOR ON THE DRAIN SIDE. THE CONNECTOR WAS SHEARED OFF THE HUB. A HEMOSTAT WAS IMMEDIATELY PLACED ON THE CATHETER AN PROVIDERS AND ATTENDING NOTIFIED THAT THE CATHETER HAD BROKEN OFF. THE FAILURE AT THIS JOINT IN THE CATHETER CANNOT BE IDENTIFIED TO ANY SPECIFIC EVENT THAT HAPPENED PRIOR TO THE DISCOVERY OF THE FAILURE. THE CATHETER WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761427 IRRAFLOW DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM IRRAS USA, INC 2022-09-01 1000902

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR