BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 24017142 · Received January 9, 2026

    Report

    Report Number
    3003442380-2025-18469
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    October 26, 2025
    Report Date
    March 11, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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 10-JAN-2025 AGAINST "LOT NUMBER" 6010496 AND SIMILAR MALFUNCTION CODES: OCCLUSION ISSUES-CANNOT BE DETERMINED, OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). IF THERE IS NO TROUBLESHOOTING, INCONCLUSIVE TROUBLESHOOTING, OR PARTIAL TROUBLESHOOT DONE AND IT CANNOT BE CONCLUDED TO BE INFUSION RELATED, REFER TO CANNOT BE DETERMINED. NO ESCALATION REQUIRED. ONE NON-CONFORMANCE (NC) WAS FOUND. THIS ISSUE IS RELATED TO STERILIZATION PROCESS WHICH IS NOT LINKED TO THE PERFORMANCE OF THE PROCESS. THE REVIEW CONFIRMED THAT LOT 6010496 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 10-JAN-2025 AGAINST "LOT NUMBER" CRITERIA EQUAL 6010496 AND SIMILAR MALFUNCTION CODES OCCLUSION ISSUES-CANNOT BE DETERMINED, OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). IF THERE IS NO TROUBLESHOOTING, INCONCLUSIVE TROUBLESHOOTING, OR PARTIAL TROUBLESHOOT DONE AND IT CANNOT BE CONCLUDED TO BE INFUSION RELATED, REFER TO CANNOT BE DETERMINED. NO ESCALATION REQUIRED. THE COUNT OF COMPLAINT IS 3, COMPLAINT 2300078, 2491029 AND 2514489. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010496 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 AND MANUFACTURED IN THE INSET 3 ON 16-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. GLUING TUBE THE 5B01321 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66 ON 15-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE 5B00196 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66 ON 05-FEB-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 INDICATES NONCONFORMANCE; ESCALATION AND CORRECTIVE ACTIONS REQUIRED PER QUALITY PROCEDURES. 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 1 AIR FLOW TEST FOR COMPLAINTS AREA VERSION 2: ALL 3 SAMPLES TESTED PASSED FUNCTIONAL TESTING. ALL TEST RESULTS WERE WITHIN SPECIFICATION AS DOCUMENTED IN THE ATTACHED TEST REPORT COMPLAINT (B)(4). 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 ABOVE INVESTIGATION, FURTHER INVESTIGATION WAS REQUIRED BECAUSE THE FOLLOWING THRESHOLD WAS MET 3 OR MORE COMPLAINTS EXIST FOR THE SAME LOT AND SIMILAR MALFUNCTIONS. STATISTICAL ANALYSIS RESULT: AFTER ASSESSMENT OF THE FAILURE VIA PRODUCT TRENDING OVER TIME WITH CONTROL CHARTS, THE RISK HAS BEEN DEEMED AS WITHIN ACCEPTED LIMITS. NO FURTHER ACTION IS REQUIRED. (B)(4). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORT 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 6010496 AND RELATED MALFUNCTION CODES FOR OCCLUSION ISSUES-CANNOT BE DETERMINED. 3 COMPLAINTS WERE IDENTIFIED FOR THIS LOT AND BASED ON THE ASSESSMENT OF THE MALFUNCTION AND PRODUCT FAMILY TRENDING OVER TIME; THE RISK HAS BEEN DEEMED WITHIN ACCEPTED LEVEL. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED, AND NO FURTHER INVESTIGATION IS REQUIRED. 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 WAS HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS 536 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. THE LENGTH OF HOSPITALIZATION WAS FOR 4 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399085 INSET UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001680 6010496

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female Required Intervention