BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET GUARD

    MDR report key: 24701362 · Received March 26, 2026

    Report

    Report Number
    8021545-2026-99906
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    September 6, 2023
    Report Date
    February 25, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022928
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL (B)(4) - DEVICE 3 OF 5. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: THE UNITED STATES. UNOMEDICAL HEREBY SUBMITS THIS INITIAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CORRECTIVE AND PREVENTIVE ACTION (CAPA)/FDA ACTION PLAN. THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS INITIAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAINS UNCHANGED BASED ON THE REVIEW COMPLETED ON 25-FEB-2026 AND INVESTIGATION COMPLETED ON 18-MAR-2026 THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED AS THE INITIAL REPORT. COMPLAINT INVESTIGATION RESULTS: REVIEW OF COMPLAINT RECORD DATABASE 1761078 EVENT DESCRIPTION AND ALL AVAILABLE INFORMATION WAS COMPLETED, AND LOT NUMBER 5385887 WAS PROVIDED. COMPLAINT WAS CLASSIFIED UNDER MALFUNCTION CODE: INFUSION SITE EGRESS TRACE MOISTURE / SUPERFICIAL WETNESS. A QUERY WAS RUN IN THE ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) ON 18-MAR-2026 AGAINST LOT NUMBER 5385887 AND SIMILAR MALFUNCTION CODE(S). INFUSION SITE EGRESS TRACE MOISTURE / SUPERFICIAL WETNESS. INFUSION SITE LEAKAGE TRACE MOISTURE / SUPERFICAL WETNESS. INFUSION SITE LEAKAGE TRACE MOISTURE / SUPERFICAL WETNESS. LEAKAGE INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED) LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED) NO RECORDS WERE IDENTIFIED FOR THIS LOT AND SIMILAR RELATED ISSUES. A NON CONFORMANCE (NC)/CAPA QUERY SEARCH WAS RUN IN THE EQMS SYSTEM PERFORMED ON 18-MAR-2026 AGAINST LOT/BATCH NUMBER 5385887. NO RECORDS WERE FOUND. DEVICE HISTORY RECORD (DHR) REVIEW: THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 5385887 WAS REVIEWED. 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 OF COMPLAINT INVESTIGATION: LOT NO. 5385887 WAS PROVIDED, HOWEVER, AS THE COMPLAINT IS CATEGORIZED AS A REPORTABLE WITH NO HARM REPORTED AND NO ISSUES WERE FOUND DURING EQMS SEARCH AND DHR REVIEW: NO VISUAL INSPECTION IS REQUIRED TO BE PERFORMED. NO RETAIN SAMPLE TESTING IS REQUIRED TO BE CONDUCTED.NO FURTHER ASSESSMENT WILL BE MADE REGARDING POTENTIAL PRODUCT PERFORMANCE ISSUES, COMPONENT INTEGRITY, OR MANUFACTURING DEFECTS. CAPA DETERMINATION: BASED ON THE AVAILABLE INFORMATION, NO FURTHER INVESTIGATION IS REQUIRED NOR CAPA PLAN IS NEEDED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING (MONTHLY TRIPS AND ALERTS). ROOT CAUSE OF PROBLEM: N/A THIS COMPLAINT DID NOT REQUIRE ESCALATION TO CAPA, THEREFORE NO FURTHER ROOT CAUSE INVESTIGATION HAS BEEN COMPLETED. CORRECTIVE ACTION AS A RESULT OF THE INVESTIGATION: N/A - THIS COMPLAINT DID NOT REQUIRE ESCALATION TO CAPA, THEREFORE NO CAPA PLAN IS AVAILABLE. SUMMARY CONCLUSION: BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION HAS BEEN PERFORMED, AND THE COMPLAINT COULD NOT BE CONFIRMED AS ANALYZED. THEREFORE, THE COMPLAINT IS CLOSED BASED ON THE EVENT DESCRIPTION AND ALL INFORMATION MADE AVAILABLE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE AT THE SITE ON (B)(6) 2023. THE INFUSION SET HAD BEEN IN USE FOR ONE DAY, AND A TOTAL OF FIVE INFUSION SETS WERE REPORTED TO HAVE FAILED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765911 INSET GUARD UNO EWIS BLUE 60/6 HCAP 1-PK INT FPA UNOMEDICAL A/S MMT-431AJ 5385887 05705244022928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown