BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET 30

    MDR report key: 23689758 · Received December 2, 2025

    Report

    Report Number
    3003442380-2025-17052
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 19, 2025
    Report Date
    January 8, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018365
    PMA / PMN Number
    K061374
    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. ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 07/JAN/2026 AGAINST "LOT NUMBER" "6013119" AND SIMILAR MALFUNCTION CODES: SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, ICD-PMC09.04 SOFT CANNULA BENT (NO HARM), SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - REDUCED FLOW, SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE. THE REVIEW CONFIRMED THAT LOT 6013119 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 07/JAN/2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6013119" AND SIMILAR MALFUNCTION CODES: SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA BENT (NO HARM), ICD-PMC03.04.01 SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - REDUCED FLOW, SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE. THE COUNT OF COMPLAINTS IS 1. THE COMPLAINT NUMBERS IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013119 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 30 AND MANUFACTURED IN THE LINE 1, ON 29/APR/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. 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-001031 (MONTHLY TRIPS AND ALERTS). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: 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# 60013119 AND RELATED MALFUNCTION CODES. ONE COMPLAINT WAS 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. FOR MORE DETAILS, SEE THE INFORMATION UNDER THE CHILD INVESTIGATION RECORD (B)(4).

    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 EVENT AND WENT TO THE EMERGENCY ROOM (ER) ON (B)(6) 2025 AND GOT HOSPITALIZED DUE TO HYPERGLYCEMIA EVENT. THE EVENT OCCURRED THREE OR MORE HOURS AFTER INSERTION. THE INSERTION SITE WAS ABDOMEN.THE PATIENT WAS IN EMERGENCY ROOM FOR THREE DAYS.THE BLOOD GLUCOSE LEVEL WAS 550 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. THE PATIENT WAS POSITIVE FOR KETONES.THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2025. 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
    2736654 INSET 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002825 6013119 05705244018365

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention