BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 22870019 · Received August 22, 2025

    Report

    Report Number
    3003442380-2025-13130
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    July 29, 2025
    Report Date
    September 5, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244016927
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4). DEVICE 1 OF 2.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4 ) MDR 3003442380-2025-13130. 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 6010440, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 01-SEP-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL 6010440. THE COUNT OF COMPLAINTS IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010440 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 AND MANUFACTURED IN THE L-3 ON 03-DEC-2024, WITH A TOTAL OF (B)(4). 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, THE RETURNED SAMPLE(S) FROM THE LOT HAVE BEEN REQUESTED. NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED. NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, ONE COMPLAINT IN THRESHOLDS IDENTIFIED FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, NO FURTHER ACTIONS ARE REQUIRED. AS A RESULT OF THE POST MARKET SURVEILLANCE ACTIVITIES, THIS COMPLAINT HAS BEEN EVALUATED AS A TYPE 4 (ESCALATED TO CAPA): THIS IS A COMPLAINT WHICH IS BEING ADDRESSED AS PART OF A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1768101 AUTOSOFT 90, KINKED SOFT CANNULA ISSUES WHICH HAS BEEN OPENED AS RESULT OF TRENDING ACTIVITIES. THIS IS A COMPLAINT WHICH IS BEING ADDRESSED AS PART OF A CAPA 1768101: "AUTOSOFT 90, KINKED SOFT CANNULA ISSUES WHICH HAS BEEN OPENED AS A RESULT OF TRENDING ACTIVITIES. THIS COMPLAINT IS A REPORTABLE WITH VALID LOT NUMBER/PRODUCT CODE. CAPA DETERMINATION RESULTS: THIS COMPLAINT FALLS UNDER THE SCOPE OF THE CAPA 1768101: "AUTOSOFT 90, KINKED SOFT CANNULA ISSUES" AND WILL COVER INSET I (AUTOSOFT XC DHF-13.8 & 13.13) AND INSET II (AUTOSOFT 90 DHF-14 AND 14.3) PRODUCTS. ROOT CAUSE OF PROBLEM: THE ROOT CAUSE HAS BEEN IDENTIFIED AS: METHOD, MANPOWER, MEASUREMENT, MACHINE: CORRECTIVE ACTION AS A RESULT OF THE INVESTIGATION: THE ACTION PLAN AND DEADLINES IS AS FOLLOWED: THE FOLLOWING ACTIONS WERE ALREADY IMPLEMENTED IN THE NC 1. INCLUDE THE DEFECT IN DOCUMENT (B)(4) (WORK INSTRUCTION INSET LINE). 2. IMPROVE GUARDS OF THE CONVEYORS. 3. UPDATE TRAYS FOR THE STOCK OF CANNULAS. 4. UPDATE DOCUMENT (B)(4) (QUALITY SPECIFICATION FOR CATHETER FIXTURE FOR SKEWED CATHETERS) FOR INCLUDE THE HANDLING OF THE CATHETER DURING THE PROCESS. 5. UPDATE THE DOCUMENT (B)(4) (WORK INSTRUCTION INSET LINE) TO INCLUDE THE PREVENTIVE ACTIONS IMPLEMENTED IN THE PROCESS (TRAYS). A REMAINING ACTION (TO ADDRESS DESIGN ROOT CAUSE) AND DEADLINES IS AS FOLLOWED: ADD CYLINDERS TO THE LID TO MAINTAIN IN POSITION THE NEEDLE AND CANNULA DURING TRANSPORTATION AND PRIOR USE (DATABASE 1771074- 30/SEP/2025).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THIS EMDER IS BEING SUBMITTED FOR UNKNOWN NUMBER QUANTITY. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS (DKA) ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS 503 MG/DL AT THE TIME OF EVENT AND WAS CAUSED BY KINKED CANNULA.THE KINKED CANNULA EVENTS OCCURRED THREE OR MORE HOURS AFTER INSERTION. THE INSERTION SITE WAS THE ABDOMEN. THE INFUSION SETS WERE IN USE FOR 4 TO 5 HOURS. PATIENT WAS FOUND POSITIVE FOR HIGH KETONES LEVEL AND KETONE LEVELS WERE FOUND TO BE LIFE-THREATENING. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    1661119 INSET UNO INSET I 110/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001728 6010440 05705244016927

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Life Threatening