BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 22093684 · Received May 28, 2025

    Report

    Report Number
    3003442380-2025-09994
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    April 23, 2025
    Report Date
    October 9, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244025202
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2025-09994), WAS SUBMITTED ON 28-MAY-2025. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 11-DEC-2024. 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. THE REFERENCE SAMPLES FOR THE LOT 6010684 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 19/JUN/2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT OF COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010684 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 MANUFACTURED IN THE LINE L-3, LI74, ON 11/DEC/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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 10/JUL/2025 AGAINST MALFUNCTION CODE EVALUATED SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE AND LOT 6010684 AND OTHER 2 COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: 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 NON-CONFORMANCE (NC) 1515780. 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).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED STATES. ON (B)(6) 2025, THE PATIENT EXPERIENCED A SIGNIFICANT INCREASE IN THEIR BLOOD GLUCOSE LEVELS. UPON INVESTIGATING THE CAUSE, THEY REMOVED THEIR INFUSION SET AND DISCOVERED THAT THE CANNULA WAS BENT, LIKELY CONTRIBUTING TO THE GLUCOSE ELEVATION. THE SITUATION WAS SERIOUS ENOUGH TO REQUIRE IMMEDIATE MEDICAL INTERVENTION. THE PATIENT RECEIVED INITIAL TREATMENT ON-SITE WITH INTRAVENOUS FLUIDS. SUBSEQUENTLY, THEY WERE TRANSPORTED TO THE EMERGENCY ROOM FOR FURTHER CARE, WHERE INSULIN WAS ADMINISTERED VIA INJECTION TO HELP STABILIZE THEIR BLOOD GLUCOSE LEVELS. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. 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
    330341 INSET UNO INSET I 60/6 GREY BETA 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. FG000016-01 6010684 05705244025202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention