BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET II

    MDR report key: 25342633 · Received May 31, 2026

    Report

    Report Number
    3003442380-2026-24333
    Event Type
    Injury
    Date Received
    May 31, 2026
    Date of Event
    May 3, 2026
    Report Date
    May 5, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A DE C.V
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: EVENT CITY: (B)(6) EVENT COUNTRY: ITALY NAME: (B)(6) COUNTRY: UNITED STATES OF AMERICA STREET (B)(6). IMDRF CAUSE INVESTIGATION CODE: CODE B24 IS NOT AVAILABLE IN DATABASE TO CAPTURE EVENT HISTORY LOG REVIEW 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 27-MAY-2026 AGAINST "LOT NUMBER 6013912 AND SIMILAR MALFUNCTION CODES: MALFUNCTION CANNOT BE DETERMINED - MEDICAL INTERVENTION REQUIRED. MALFUNCTION CANNOT BE DETERMINED. THE REVIEW CONFIRMED THAT LOT NUMBER 6013912 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 27/MAY/2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6013912 AND SIMILAR MALFUNCTION CODES: MALFUNCTION CANNOT BE DETERMINED - MEDICAL INTERVENTION REQUIRED. MALFUNCTION CANNOT BE DETERMINED. THE NUMBER OF COMPLAINTS IS 1. THE COMPLAINT NUMBER IS COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013912 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 124 AND MANUFACTURED IN THE LINE LI75 - L7, ON 20/JUN/2025 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING, LOT 5F02228 WAS MANUFACTURED ACCORDING TO THE WI VERSION 68 AND MANUFACTURED IN THE GLUING MACHINE SC01, ON 19-JUN-2025, WITH A TOTAL OF(B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING, LOT 5F01698 WAS MANUFACTURED ACCORDING TO THE WI VERSION 68 AND MANUFACTURED IN THE GLUING MACHINE SC01, ON 21-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. RETAIN SAMPLES TESTING: BASED ON THE CLASSIFICATION OF THE MALFUNCTION CODE, THIS TYPE OF ISSUE DOES NOT REQUIRE VISUAL TESTING, FUNCTIONAL TESTING, OR EVALUATION OF RETAIN SAMPLES, AS IT CORRESPONDS TO CATEGORIES SUCH AS "MISUSE, USER RELATED ISSUES, OR NO MALFUNCTION ALLEGED." THEREFORE, NO RETAIN SAMPLES WERE REQUESTED AND NO PRODUCT TESTING WAS PERFORMED. CONCLUSION: NO FURTHER INVESTIGATION ACTIVITIES WERE REQUIRED. RETURN SAMPLES TESTING: RETURNED SAMPLE FROM THE RELEVANT LOT WAS 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 WORK INSTRUCTION (WI) (MONTHLY TRIPS AND ALERTS). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING 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 6013912 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. PHOTOS/SAMPLES WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT NO PHOTOS/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. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 8021545 MANUFACTURING SITE: 3003442380.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 490MG/DL ON (B)(6) 2026. THE PATIENT RECEIVED TREATMENT WITH IV FLUIDS AND SALINE. DURATION OF HOSPITAL STAY WAS ABOUT SEVEN HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392327 INSET II SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL DEVICES S.A DE C.V 1002817 6013912 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1