BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE 16 FR SILICONE FOLEY CATHETER

    MDR report key: 22873398 · Received August 22, 2025

    Report

    Report Number
    MW5175115
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    August 14, 2025
    Report Date
    August 15, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT
    Product Code
    PPB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FOLEY CATHETER BALLOON RUPTURE WHILE IN PATIENT. A SECOND FOLEY CATHETER OF THE SAME MANUFACTURER AND LOT NUMBER WAS TESTED FOR PROPER INFLATION (NOT IN A PATIENT) AND THE BALLOON RUPTURED AGAIN AFTER APPROXIMATELY 5ML OF SALINE WAS INJECTED INTO THE BALLOON. DEVICE CODE: 1546. PATIENT CODE: 4580. REFERENCE REPORT# MW5175114.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2871937 MEDLINE 16 FR SILICONE FOLEY CATHETER FOLEY CATHETER KIT (EXCLUDES HIV TESTING) PPB MEDLINE INDUSTRIES, LP - SPT 25DBT548

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| H