BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURYN SMARTFOLEY UO TEMP TRAY SYSTEM 16FR

    MDR report key: 15657362 · Received October 24, 2022

    Report

    Report Number
    15657362
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    July 22, 2022
    Report Date
    October 3, 2022
    Manufacturer
    POTRERO MEDICAL, INC.
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INSERTED FOLEY CATHETER, URINE RETURN PRESENT. BALLOON INFLATED AFTER URINE RETURN PRESENT W/ 2 RN VERIFICATION. DURING PROCEDURE, ONLY 4 ML OF URINE OUTPUT. FOLEY CATHETER FLUSHED WITH URINE AND ACCURYN MACHINE CHANGED AS WELL. NO URINE OUTPUT. AT END OF CASE, CATHETER WAS HALFWAY OUT OF URETHRA AND BALLOON WAS NOT INFLATED. BLOOD WAS ALSO IN THE CATHETER. FOLEY CATHETER REPLACED WITH URINE RETURN AND 2 RN VERIFICATION PER POLICY, BALLOON INFLATED AFTER URINE RETURN. IMMEDIATE URINE OUTPUT OF 200-300 MLS BEFORE TRANSFERRING PATIENT TO CARDIAC ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495338 ACCURYN SMARTFOLEY UO TEMP TRAY SYSTEM 16FR CATHETER, RETENTION TYPE, BALLOON EZL POTRERO MEDICAL, INC. FGS-06-UOT.16FST C21120101

    Patients

    Seq Age Sex Outcome Treatment
    1 26645 DA Male