BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-PORT ADVANCE

    MDR report key: 23210434 · Received October 3, 2025

    Report

    Report Number
    3003442380-2025-14619
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 9, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K120337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6002849, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002849 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 25 AND MANUFACTURED IN THE LINE I-PORT ON 21-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. AN EXTENDED FOR BROKEN SLEEVE WAS PERFORMED FOR THE OUTGOING TEST 6(G). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: ONE NON-CONFORMANCE (NC) WAS RAISED DURING THE PROCESS UNRELATED TO THE MALFUNCTION REPORTED, THEREFORE, NO NC RAISED RELATED TO COMPLAINT CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(4). PATIENT COUNTRY: RUSSIAN FEDERATION.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN RUSSIAN FEDERATION. ON (B)(6) 2025, PATIENT EXPERIENCED INFUSION SET LEAKAGE ISSUE. THE LEAKAGE WAS DETECTED AT THE TOP OF SEPTUM. THE ISSUE WAS RESOLVED BY CHANGING INFUSION SET. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2458755 I-PORT ADVANCE I-PORT ADVANCE 6 MM FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-100 6002849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown