BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 23449063 · Received November 3, 2025

    Report

    Report Number
    3003442380-2025-15747
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    September 23, 2025
    Report Date
    November 8, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2025-15747 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 6011576, IN QUESTION WAS MANUFACTURED AT THE: REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 28-OCT-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6011576". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011576 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 AND MANUFACTURED IN THE LINE 5 ON 06-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT DURING THE FINAL INSPECTION OUTGOING, TEST NUM 4: D A SAMPLE WAS FOUND WITH THE SLEEVE NOT ASSEMBLY PROPERLY. ACCORDING TO THE SAMPLING PLAN PERFORMED THE LOT WAS RELEASED. 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. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: - (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST AND - (WI) GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2: 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 TEST OF REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, HOWEVER, A SAMPLING PLAN EXTENDED WAS PERFORMED DURING FINAL INSPECTION OUTGOING PROCESS NO RELATED TO COMPLAINT CODE, NO THRESHOLDS IDENTIFIED FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, 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 RESULT OF TRENDING ACTIVITIES. 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. CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION RESULTS: THIS COMPLAINT FALLS UNDER THE SCOPE OF THE CORRECTIVE AND PREVENTIVE ACTION (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 NON-CONFORMANCE (NC) · 1. INCLUDE THE DEFECT IN DOCUMENT 4805074 (WORK INSTRUCTION INSET LINE). · 2. IMPROVE GUARDS OF THE CONVEYORS. · 3. UPDATE TRAYS FOR THE STOCK OF CANNULAS. · 4. UPDATE DOCUMENT 3A02003 (QUALITY SPECIFICATION FOR CATHETER FIXTURE FOR SKEWED CATHETERS) FOR INCLUDE THE HANDLING OF THE CATHETER DURING THE PROCESS. · 5. UPDATE THE DOCUMENT 4805074 (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).

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4). MDR 3003442380-2025-15747 - DEVICE 1 OF 2.

    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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WENT TO EMERGENCY ROOM ON (B)(6) 2025 DUE TO HYPERGLYCEMIA. THE HYPERGLYCEMIA EVENT OCCURRED DUE TO BENT CANNULA ISSUE OF INFUSION SETS. THE BLOOD GLUCOSE LEVEL WAS 585 MG/DL AT THE TIME OF EVENT AND PATIENT GOT TREATED WITH INTRAVENOUS INSULIN AND FLUIDS. THE PATIENT STAYED IN THE HOSPITAL FOR COUPLE OF HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076946 INSET UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001680 6011576 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention