BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRAFLOW CATHETER 2.0

    MDR report key: 13056388 · Received December 21, 2021

    Report

    Report Number
    3017865540-2021-00001
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    May 15, 2021
    Report Date
    June 15, 2021
    Manufacturer
    IRRAS USA, INC.
    Product Code
    GWM
    UDI-DI
    00868643000432
    PMA / PMN Number
    K171880
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IRRAFLOW CATHETER WAS PLACED IN PATIENT. NURSE NOTICED WATER LEAKAGE IN PATIENT'S BED AT PATIENT'S RIGHT ARM. TUBING AND STOPCOCK HAD BROKEN. CATHETER WAS PLACED IN OR BY DR. (B)(6) ON (B)(6) 2021. ON (B)(6) 2021, RN (B)(6) DISCOVERED THAT THERE WAS WATER IN THE BED BY THE PATIENT'S RIGHT ARM DURING THE BED BATH. ALSO, THE TUBING AND STOPCOK FELL APART AND THE WATER LEAKAGE MAY HAVE BEEN OCCURRING FOR SOME TIME. (B)(6) TOOK OFF THE BROKEN STOPCOCK AND DISCARDED IT. A CT SCAN OF THE PATIENT'S BRAIN SHOWED THAT THERE WAS AIR IN THE VENTRICLES. HOWEVER, THE PATIENT DID NOT NED A CATHETER REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955985 IRRAFLOW CATHETER 2.0 CATHETER 2.0 GWM IRRAS USA, INC. 2.0 00868643000432

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose