BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE SELECT SILICONE FOLEY CATHETER TRAY

    MDR report key: 23532347 · Received November 12, 2025

    Report

    Report Number
    MW5178731
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 6, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT
    Product Code
    OHR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FOLEY CATHETER TRAY SYRINGE TO FILL FOLEY DID NOT HAVE ANY WATER IN IT ONLY AIR. IN ADDITION, THE PATIENT HAS HAD TO HAVE 3 FOLEYS REPLACED BECAUSE THE BALLOONS DEFLATED AND THE CATHETER CAME OUT OF THE PATIENT. ON (B)(6) 2025, FOUND CATHETER OUT OF PATIENT WITH BALLOON DEFLATED. WHEN THE NURSE WENT TO REPLACE THE FOLEY FOUND THE SYRINGE TO FILL BALLOON WITH AIR, NOT WATER. NURSE RETRIEVED A SECOND TRAY, SYRINGE DID HAVE WATER IN IT, FOLEY WAS PLACED. SUBSEQUENTLY, THE SAME PATIENT, THE NURSE CHECKED CATHETER BECAUSE IT WAS NOT DRAINING, BALLOON HAD DEFLATED, CATHETER HAD TO BE REPLACED. PT CODE: 4564. DEVICE CODES: 4004, 4061. REF REPORTS: MW5178732, MW5178733.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140204 MEDLINE SELECT SILICONE FOLEY CATHETER TRAY CATHETER CARE TRAY OHR MEDLINE INDUSTRIES, LP - SPT DYND11523 25GBJ327

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male