BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 19484707 · Received June 7, 2024

    Report

    Report Number
    3003442380-2024-06951
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    April 25, 2024
    Report Date
    August 16, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    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

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER, EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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 INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE. THE BATCH 6002758 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. THE REFERENCE SAMPLES FOR BATCH 6002758 WERE PREVIOUSLY TESTED IN 1834172 ON 23/FEB/2024. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING LOT 1882017 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 106 IN THE LINE L-5, ON 14/AUG/2023, WITH A TOTAL OF (B)(4). REVIEW OF THE DEVICE HISTORY RECORD (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 11/AUG/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE AND LOT 6002758 AND OTHER 3 COMPLAINTS HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6002758 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.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET SOFT CANNULA BENT EVENT ON (B)(6) 2024. INSERTION SITE WAS AT THIGH. THE SET WAS IN USE FOR A DAY AND A HALF AND THE EVENT OCCURRED AFTER THREE HOURS OF INSERTION. BLOOD GLUCOSE LEVELS WERE 600 MG/DL AND PATIENT WAS ALSO HAVING MODERATE LEVELS OF KETONES AT THE TIME OF EVENT. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. UNOMEDICAL 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
    1099679 INSET UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6002758 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female