BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET I

    MDR report key: 22824629 · Received August 18, 2025

    Report

    Report Number
    3003442380-2025-12846
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    July 11, 2025
    Report Date
    September 26, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244022386
    PMA / PMN Number
    K032854
    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 6010070 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 25/SEP/2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH" , "LOT NUMBER" CRITERIA EQUAL "6010070" . THE COUNT OF COMPLAINT IS 2 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010070WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 118 AND MANUFACTURED IN THE LINE 3 ON 09/NOV/2024, 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: PHYSICAL SAMPLES WERE REQUESTED; HOWEVER, THE CUSTOMER HAS CONFIRMED THAT NO SAMPLES ARE AVAILABLE FOR TESTING. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: THE REFERENCE SAMPLES COULD NOT BE TESTED BECAUSE THEY WERE USED BY THE QUALITY DEPARTMENT FOR AN INVESTIGATION. 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 AND FINAL REPORTING DECISION, NO FURTHER ACTIONS ARE REQUIRED. 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 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 (B)(4) 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 (B)(4) - (B)(6) 2025).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025. BLOOD GLUCOSE LEVEL AT THE TIME OF EVENT WAS 400 MG/DL CAUSED BY BENT CANNULA EVENT WHICH LED TO OCCLUSION AND THE PATIENT GOT TREATED WITH INTRAVENOUS AND FLUIDS OF SALINE AND INSULIN. PATIENT WAS FOUND POSITIVE FOR MODERATE KETONES LEVEL AND KETONE LEVELS WERE FOUND TO BE LIFE-THREATENING. THE PATIENT IS STILL IN THE HOSPITAL. 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
    2194311 INSET I UNO INSET I 12/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1006922 6010070 05705244022386

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| L| R