BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE FOLEY CATHETER KIT

    MDR report key: 23693391 · Received December 2, 2025

    Report

    Report Number
    MW5179697
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    November 17, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT
    Product Code
    PPB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FOLEY CATHETER LEAKING FROM THE INFLATION PORT. MULTIPLE NURSES HAVE COMPLAINED ABOUT THIS. ALSO WITH THESE NEW FOLEY KITS, THE SECURE LOCK DEVICE SOMETIMES BREAKS DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959268 MEDLINE FOLEY CATHETER KIT FOLEY CATHETER KIT (EXCLUDES HIV TESTING) PPB MEDLINE INDUSTRIES, LP - SPT 10193489987461 25DB1247

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention