BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIZE KUO DISPOSABLE PEDIATRIC KIT

    MDR report key: 23988614 · Received January 7, 2026

    Report

    Report Number
    23988614
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 5, 2025
    Report Date
    December 15, 2025
    Manufacturer
    FIZE MEDICAL LTD.
    Product Code
    EXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT ARRIVED TO PICU [PEDIATRIC INTENSIVE CARE UNIT] FROM OR POST KIDNEY TRANSPLANT WITH 'OLD' FOLEY CATHETER DRAINAGE SYSTEM. PICU DID NOT HAVE A COMPATIBLE UROMETER, ONLY THE NEW FIZE MEDICAL COLLECTION SYSTEMS. THERE WAS A DELAY IN MONITORING THE PATIENT'S URINE OUTPUT. PICU EVENTUALLY FOUND THE CORRECT FIZE TUBING. PER BEDSIDE REPORT, OR INITIALLY PLACED PATIENT ON NEW FIZE DEVICE, BUT STATED THAT IT "DID NOT WORK." PICU ASSUMES THAT THE OR DIDN'T SEE URINE FREE FLOWING IN THE TUBING AND ASSUMED IT WASN'T WORKING. CHART REVIEWED. DISCUSSED CASE WITH OR MANAGEMENT, FIZE TEAM, PICU CNS [CLINICAL NURSE SPECIALIST], AND CLINICAL ENGINEERING. WILL COACH AND DEBRIEF WITH INVOLVED STAFF. NEW FIZE UROMETER TIP SHEET CREATED AND SENT OUT TO STAFF LAST NIGHT, INCLUDING HOW TO VISUALIZE URINE RETURN AND PROPER PLACEMENT. COORDINATED TEACHING SESSION BETWEEN [REDACTED] FROM FIZE AND SERVICE LEAD RNS IN THE OR TO FUNCTION AS SUPER USERS/TRAIN THE TRAINER. (UPDATE FROM [REDACTED]). DRAINAGE BAGS FOR THIS SYSTEM ARE HAVING INTERFERENCE IN THE OR AND ARE EJECTING AUTOMATICALLY MID CASE FIZE KUO DISPOSABLE KIT PEDIATRIC UROMETER. REF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50507 FIZE KUO DISPOSABLE PEDIATRIC KIT UROFLOWMETER EXY FIZE MEDICAL LTD. G2 DS25060896R

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male