BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET 30

    MDR report key: 23568560 · Received November 17, 2025

    Report

    Report Number
    3003442380-2025-16519
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 23, 2025
    Report Date
    November 12, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018365
    PMA / PMN Number
    K061374
    Adverse Event
    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 6013737, IN QUESTION WAS MANUFACTURED AT THE: REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 12-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6013737". THE COUNT OF COMPLAINT IS 2 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013737 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 31 AND MANUFACTURED IN THE INSET 30 L1 ON 12-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. 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. TEST RESULTS: IN ORDER TO TEST THE PRODUCT, NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED, THEREFORE, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED, HOWEVER, THE REFERENCE SAMPLES FOR THE LOT 6013737 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPALINT (B)(4) ON 07-NOV-2025. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TEST FOR COMPLAINTS AREA VERSION 3: ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. WORK INSTRUCTION (WI) GUIDANCE FOR FUNCTIONAL TESTING 1 AIR FLOW TEST FOR COMPLAINTS AREA VERSION 2: ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST FOR THE CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED. NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION UNRELATED TO COMPLAINT CODE, 2 COMPLAINTS IN THRESHOLDS IDENTIFIED FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, 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 CANADA. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET BENT CANNULA EVENT ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF THE EVENT DUE TO WHICH PATIENT HAD TO VISIT EMERGENCY ROOM. THE PATIENT WAS IN THE EMERGENCY ROOM FOR 5 TO 6 HOURS. THE PATIENT AND GOT TREATED WITH INTRAVENOUS IV AND FLUIDS OF SALINE AND INSULIN. THE PATIENT ALSO TESTED FOR KETONES WHICH SHOWED MODERATE KETONES. 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
    50237 INSET 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002825 6013737 05705244018365

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Required Intervention