BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 23655481 · Received November 26, 2025

    Report

    Report Number
    3003442380-2025-16991
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    November 14, 2025
    Report Date
    February 19, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026032
    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: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 19-DEC-2025 AGAINST "LOT NUMBER 6011714 AND SIMILAR MALFUNCTION CODES: SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE, SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - REDUCED FLOW, SOFT CANNULA BENT (NO HARM). THE REVIEW CONFIRMED THAT LOT 6011714 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NONCONFORMING REPORTS (NCR)S OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 19-DEC-2025 AGAINST "LOT NUMBER" CRITERIA EQUAL 6011714 AND SIMILAR MALFUNCTION CODES: SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE, SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL REDUCED FLOW, SOFT CANNULA BENT (NO HARM). THE COUNT OF COMPLAINT IS 7. SEE ATTACHMENT QUERY LOT 6011714 FOR SIMILAR COMPLAINTS. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011714 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 AND MANUFACTURED IN THE LINE 6 ON 15-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 5B01679 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66 AND MANUFACTURED IN THE MACHINE SC09, ON 11-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING OF THE LOT 5A06566 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66 AND MANUFACTURED IN THE MACHINE SC04, ON 30-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE OVERALL REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS, HOWEVER, A NON-CONFORMANCE (NC) 2165520 WAS OPENED DURING STERILIZATION PROCESS (SEVERAL LOADS INTERRUPTED DURING THE STERILIZATION PROCESS BY POWER OUTAGES AT STERIGENICS G.P.) AND IS NOT ASSOCIATED TO REPORTED ISSUE ON THIS COMPLAINT. CONCLUSION: DHR REVIEW IDENTIFIED MINOR FINDING. IT WAS MANAGED ACCORDING TO PROCEDURE AND DID NOT IMPACT COMPLIANCE; NO ISSUES NOTED. VISUAL EVIDENCE REVIEW: NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. RETAIN SAMPLES TESTING RETAIN SAMPLES FROM THE RELEVANT LOT WERE REQUESTED AND TESTED IN ACCORDANCE WITH APPROVED PROCEDURES: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: ALL 3 SAMPLES TESTED PASSED VISUAL INSPECTION. WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2: ALL 3 SAMPLES TESTED PASSED FUNCTIONAL TESTING FOR THE REPORTED MALFUNCTION CODE SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE, ALL TEST RESULTS WERE WITHIN SPECIFICATION AS DOCUMENTED IN THE ATTACHED TEST REPORT COMPLAINT (B)(4). THE REFERENCE SAMPLES WERE TESTED ON 04-DEC-2025. CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. RETURN SAMPLES TESTING: RETURNED SAMPLES FROM THE RELEVANT LOT WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. CONCLUSION: VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO LACK OF SAMPLE AVAILABILITY. ASSESSMENT WILL BE BASED ON OTHER AVAILABLE EVIDENCE. CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: THIS IS A COMPLAINT WHICH IS BEING ADDRESSED AS PART OF A CAPA 1768101: "AUTOSOFT 90, KINKED SOFT CANNULA ISSUES WHICH HAS BEEN OPENED AS A RESULT OF TRENDING ACTIVITIES. THIS COMPLAINT IS A REPORTABLE EVENT WITH (6008253) 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 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 DESING 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)-8SEP-2025). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT.

    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 FACED BENT CANNULA ISSUE ON (B)(6) 2025 WHICH LEADS TO HIGH BLOOD GLUCOSE LEVELS. THE EVENT OCCURRED THREE OR MORE HOURS OF INSERTION. THE INSERTION SITE WAS ABDOMEN. THE INFUSION SET WAS IN USE FOR FIVE HOURS. THE PATIENT INITIALLY WENT TO THE EMERGENCY DEPARTMENT ON (B)(6) 2025 DUE TO HIGH BLOOD GLUCOSE AND WAS SUBSEQUENTLY HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE PATIENT'S BLOOD GLUCOSE WAS 546 MG/DL AND TREATED BY INTRAVENOUS FLUIDS OF SALINE AND INSULIN. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2025. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255045 INSET INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 6011714 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H