BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET II

    MDR report key: 25342521 · Received May 31, 2026

    Report

    Report Number
    3003442380-2026-24332
    Event Type
    Injury
    Date Received
    May 31, 2026
    Date of Event
    May 18, 2026
    Report Date
    May 21, 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: PATIENT CITY: (B)(6) PATIENT COUNTRY: ITALY. NAME: (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 6012658 AND SIMILAR MALFUNCTION CODE(S): USE OF EXPIRED INFUSION SET PRODUCTS. THE REVIEW CONFIRMED THAT LOT 6012658 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 6012658 AND SIMILAR MALFUNCTION CODES USE OF EXPIRED INFUSION SET PRODUCTS. THE COUNT OF COMPLAINT IS ONE. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012658 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 122 AND MANUFACTURED IN THE LINE 7 LI75 ON 05-APR-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. 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: NO DEVICE, COMPONENTS, OR PHYSICAL EVIDENCE WERE AVAILABLE FOR EVALUATION; THEREFORE, VISUAL INSPECTION AND RETAIN-SAMPLE TESTING COULD NOT BE PERFORMED. BASED ON THE EVENT DESCRIPTION, ASSIGNED MALFUNCTION CODE, AND THE LIMITED INFORMATION PROVIDED, THE REPORTED FAILURE COULD NOT BE CONFIRMED. CONCLUSION: NO FURTHER INVESTIGATION ACTIVITIES WERE REQUIRED. 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: 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 6012658 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. 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. THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING. REQUIRED COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE 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 THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2026 DUE TO HYPERGLYCEMIA TREATED WITH INTRAVENOUS FLUIDS. PATIENT USED EXPIRED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214804 INSET II SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL DEVICES S.A DE C.V 1002817 6012658 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1