BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R15/BAG, DRAIN

    MDR report key: 23192913 · Received October 1, 2025

    Report

    Report Number
    2182318-2025-00087
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Report Date
    September 8, 2025
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    MMZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, THIS EVENT IS REPORTED BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. CONFIRMATION OF THE CUSTOMER'S COMPLAINT AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCTION TEAM AT THE MANUFACTURING SITE HAS BEEN NOTIFIED OF THIS COMPLAINT; HOWEVER, WE HAVE NOT YET RECEIVED THE ASSOCIATED DEVICE HISTORY RECORD (DHR) FOR REVIEW, NOR ANY INFORMATION REGARDING POTENTIAL PRODUCTION ISSUES. A RESPONSE FROM THE SITE IS STILL PENDING. THE INSTRUCTIONS FOR USE ARE ADEQUATE IN PROVIDING CLEAR AND CONCISE WARNINGS AGAINST PUTTING A DAMAGED CANOPY INTO USE WITH A PATIENT. THE INSTRUCTIONS STATES: INTENDED USE: AS AN ACCESSORY TO A UROLOGICAL TABLE FOR FLUID CONTAINMENT. INTENDED USERS: FOR USE BY HEALTHCARE PROFESSIONALS FOR UROLOGICAL PROCEDURES INVOLVING THE GENERAL POPULATION. DO NOT USE IF PRODUCT IS TORN OR PUNCTURED. DO NOT OVERFILL. DO NOT USE IF THE PRODUCT'S STERILE BARRIER SYSTEM OR ITS PACKAGING IS COMPROMISED. DISPOSE ACCORDING TO MEDICAL FACILITY AND MUNICIPAL GUIDELINES. REPORT ANY SERIOUS INCIDENT RELATED TO DEVICE USE TO TIDI PRODUCTS AND THE MEMBER STATE COMPETENT AUTHORITY. THIS COMPLAINT INVOLVES ONE STERILE DRAIN BAG WITH A MALE ADAPTER OF INCORRECT SIZE. AT THIS TIME, NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS PRODUCT, AND IT APPEARS TO BE AN ISOLATED INCIDENT PENDING CONFIRMATION FROM THE DHR REVIEW. MANUFACTURER REFERENCE FILE: (B)(4).

    Description of Event or Problem · 0

    THE ISSUE CONCERNS AN ADAPTER THAT DID NOT FIT SECURELY INTO THE HOSE, POTENTIALLY LEADING TO LEAKAGE DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837719 R15/BAG, DRAIN TABLE, CYSTOMETRIC, ELECTRIC MMZ TIDI PRODUCTS LLC 25217 70023682

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown