BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 24066066 · Received January 14, 2026

    Report

    Report Number
    3003442380-2025-18797
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    December 5, 2025
    Report Date
    January 14, 2026
    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

    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. ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 13/JAN/2026 AGAINST "LOT NUMBER" "6013919" AND SIMILAR MALFUNCTION CODES: SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA BENT (NO HARM), SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - REDUCED FLOW, SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE, IDD-PMC05.39 SOFT CANNULA AND INTRODUCER NEEDLE FOUND BENT/KINKED DURING INSERTION, UNABLE TO USE, SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE,SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE. THE REVIEW CONFIRMED THAT LOT 6013919 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA) OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 13/JAN/2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6013919" AND SIMILAR MALFUNCTION CODES: SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE SOFT CANNULA BENT (NO HARM), SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL REDUCED FLOW, SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE, SOFT CANNULA AND INTRODUCER NEEDLE FOUND BENT/KINKED DURING INSERTION, UNABLE TO USE, SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE.THE COUNT OF COMPLAINTS IS 0. THE COMPLAINTS NUMBERS ARE PR. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013919 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 124 AND MANUFACTURED IN THE LINE 8, ON 17/JUN/2025 WITH A TOTAL OF (B)(4) UNITS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES. ALL REQUIRED IN-PROCESS AND FINAL TESTS WERE COMPLETED AND MET SPECIFIED REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED THAT RELATE TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; 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. 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: 5 SAMPLES OUT 5 SAMPLES PASSED THE FLOW TEST FOR THE CODE SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL -BLOCKAGE. 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: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION. A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EQMS QUERIES, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD REVIEW, VISUAL EVIDENCE ASSESSMENT, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6013919 AND RELATED MALFUNCTION CODES. NO MORE COMPLAINT WERE IDENTIFIED FOR THIS LOT; HOWEVER, NO TREND OR SYSTEMIC ISSUE WAS DETECTED. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. SAMPLES WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT NO SAMPLES WERE AVAILABLE FOR ANALYSIS. CONSEQUENTLY, AN INVESTIGATION WAS CONDUCTED USING REFERENCE SAMPLES, AND NO FAILURES RELATED TO THE COMPLAINT WERE IDENTIFIED. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION AND REFERENCE SAMPLE ANALYSIS ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING.

    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 THE EMERGENCY ROOM (ER ON (B)(6) 2025 DUE TO BENT CANNULA LEADING TO HYPERGLYCEMIA THE BLOOD GLUCOSE LEVEL WAS 515 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2025. THE LENGTH OF ER STAY WAS FOR 12 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127905 INSET UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001680 6013375 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention