BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIO

    MDR report key: 22007901 · Received May 13, 2025

    Report

    Report Number
    3003442380-2025-08575
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    March 13, 2025
    Report Date
    September 12, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244020184
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6) . PATIENT COUNTRY: UNITED ARAB EMIRATES.

    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. REVISION 21 OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6001412, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001412 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 62 AND MANUFACTURED IN THE LINE LI60 ON 24-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. AN NON-CONFORMANCE (NC) 1674558 FOR UPDATE OF THEIR ACCUSOLO SOFTWARE WAS PERFORMED FOR THE STERILIZATION PROCESS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. 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, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION 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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED ARAB EMIRATES. ON (B)(6) 2025, THE PATIENT REPORTED THAT THE CANNULA OF THEIR INFUSION SET WAS TRIGGERED PREMATURELY, ACTIVATING BEFORE IT COULD BE PROPERLY INSERTED. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370685 MIO UNO INSET II 80/9 SC1 GREY MIMX FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-975A 6001412 05705244020184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown