BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT 90

    MDR report key: 22288775 · Received June 19, 2025

    Report

    Report Number
    3003442380-2025-10810
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 15, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Product Problem
    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. THE REFERENCE SAMPLES FOR THE LOT 6010193 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 10/JUL/2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW TEST. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE (B)(4) COMPLAINT TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010193 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 MANUFACTURED IN THE LINE L-4, ON 16/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 WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 08/JUL/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE AND LOT 6010193 AND FOUND OTHER 4 COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6010193 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: 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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO INFUSION SET CANNULA WAS KINKED. LEADING TO HYPERGLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS 32.5 MMOL/L AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. 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
    1496654 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002817 6010193 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention