BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRAFLOW

    MDR report key: 13367337 · Received January 26, 2022

    Report

    Report Number
    MW5107019
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Date of Event
    January 14, 2022
    Report Date
    January 24, 2022
    Manufacturer
    IRRAS USA, INC.
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    I WAS CALLED DUE TO AN IRRAFLOW BREAKING. THE RN CALLED AND SAID SHE SAW AIR AND WAS TRYING TO REMOVE IT AND THE CATHETER BROKE. I CAME IN AND ASSESSED THAT THE MALE END (DRAINAGE) OF THE CATHETER WAS BROKEN AND UNABLE TO BE RECONNECTED TO TUBING. NEUROCRITICAL CARE AND NEUROSURGERY WAS NOTIFIED. WE OCCLUDED THE DRAINAGE END AND CONNECTED THE IRRIGATION END TO AN ACCUDRAIN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812307 IRRAFLOW DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM IRRAS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male