BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET GUARD

    MDR report key: 23643308 · Received November 25, 2025

    Report

    Report Number
    8021545-2025-03284
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    November 2, 2025
    Report Date
    February 19, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018877
    PMA / PMN Number
    K173879
    Adverse Event
    Yes
    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: REVIEW OF COMPLAINT RECORD DATABASE (B)(4) EVENT DESCRIPTION AND ALL AVAILABLE INFORMATION WAS COMPLETED, AND LOT NUMBER 6013596 WAS PROVIDED. COMPLAINT WAS CLASSIFIED UNDER MALFUNCTION CODE: SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL -BLOCKAGE. A QUERY WAS RUN IN THE ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) ON 19-FEB-2026 AGAINST "BATCH/LOT NUMBER" "6013596" AND SIMILAR MALFUNCTION CODES: SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL -BLOCKAGE, SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA AND INTRODUCER NEEDLE FOUND BENT/KINKED DURING INSERTION, UNABLE TO USE, SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE. NO SIMILAR COMPLAINTS WERE IDENTIFIED FOR THIS LOT AND RELATED ISSUES. A NON-CONFORMANCE (NC)/CORRECTIVE AND PREVENTIVE ACTION (CAPA) QUERY SEARCH WAS RUN IN THE EQMS SYSTEM PERFORMED ON 19-FEB-2026 FOR AGAINST "LOT NUMBER" "6013596". NO RECORDS WERE FOUND WITH LOT 6013596 REFERENCED. DEVICE HISTORY RECORD (DHR) REVIEW: THE DEVICE HISTORY RECORD (DHR) FOR LOT 6013596 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. RETAIN SAMPLE TESTING: NO PRODUCTS OR PICTURES WERE RETURNED WITH THE COMPLAINT TO AID IN THE INVESTIGATION. RETENTION SAMPLES FROM LOT 6013596 WERE RECOVERED AND TESTED. ALL TEST RESULTS WERE WITHIN SPECIFICATION AS DOCUMENTED IN THE ATTACHED TEST REPORT: (B)(4) DATABASE COMPLAINT (B)(4) COMPLAINT . TEST REPORT IN THE CHILD RECORD DATABASE (B)(6). 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). SUMMARY CONCLUSION: DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; NO ISSUES IDENTIFIED. TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION AND THE INVESTIGATION PERFORMED, THE COMPLAINT WILL BE CLOSED AS COMPLAINT UNCONFIRMED AS ANALYZED.

    Additional Manufacturer Narrative · 0

    PATIENT COUNTRY: SPAIN. PATIENT CITY: (B)(6).

    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 SPAIN. IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS SUBSEQUENTLY HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA. THE PATIENT WAS IN THE HOSPITAL FOR FIVE HOURS. THE PATIENT STATED THAT THE HIGH BG EVENT WAS DUE TO A BENT CANNULA. THE PATIENT REPORTED FEELING TIRED AT THE TIME OF ADMISSION. THE BLOOD GLUCOSE LEVEL WAS 242MG/DL AT THE TIME OF ADMISSION AND THE PATIENT GOT TREATED WITH INSULIN PUMP AND PEN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2790448 INSET GUARD UNO MIO ADV. GREY 60/6 SC1 10-PK INT FPA UNOMEDICAL A/S MMT-242A 6013596 05705244018877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention