BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET GUARD

    MDR report key: 22113359 · Received May 30, 2025

    Report

    Report Number
    8021545-2025-01360
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 3, 2025
    Report Date
    November 14, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022805
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: SPAIN. SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED BRAND NAME UNDER D1 AND MANUFACTURING DATE UNDER H4. 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 6011221 IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE 6011221 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) APPENDIX 1 BATCHCARD FOR PRODUCTION OF PACKAGING ROOM ON 22-JAN-2025 WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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. TEST RESULTS: NO PRODUCT WAS RETURNED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION, 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 OCCURRED IN SPAIN. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET TUBING DETACHED EVENT ON (B)(6) 2025 AT SITE. THE INSERTION SITE WAS THE RIGHT ABDOMEN. INFUSION SET WAS USED FOR 2 DAYS. NO FURTHER INFORMATION WAS 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
    26213 INSET GUARD UNO EWIS BLUE 60/9 HCAP 10PK INT FPA UNOMEDICAL A/S MMT-441A 6011221 05705244022805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown