BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 23692584 · Received December 2, 2025

    Report

    Report Number
    3003442380-2025-17097
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 22, 2025
    Report Date
    December 30, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4). DEVICE 2 OF 3.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2025-17097. 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 30-DEC-2025 AGAINST "LOT NUMBER" 6012424 AND SIMILAR MALFUNCTION CODES: TUBING IS DAMAGED (E.G. KINKED, DEFORMED, TWISTED, COLLAPSED OR PINCHED), OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS- REDUCED FLOW, OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS- BLOCKAGE. THE REVIEW CONFIRMED THAT LOT 6012424 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 30-DEC2025 AGAINST "LOT NUMBER" CRITERIA EQUAL 6012424 AND SIMILAR MALFUNCTION CODES: TUBING IS DAMAGED (E.G. KINKED, DEFORMED, TWISTED, COLLAPSED OR PINCHED), OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS- REDUCED FLOW OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS- BLOCKAGE. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012424 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 121 AND MANUFACTURED IN THE LINE 10 ON 18-MAR-2025 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 5C02463 WAS MANUFACTURED ACCORDING TO THE FORM-001865 VERSION 02 AND MANUFACTURED IN THE MACHINE ITL03, ON 15-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING OF THE LOT 5B05647 WAS MANUFACTURED ACCORDING TO THE FORM-001865 VERSION 02 AND MANUFACTURED IN THE MACHINE ITL03, ON 09-MAR-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 (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 6012424 AND RELATED MALFUNCTION CODES FOR TUBING DAMAGED. ONE COMPLAINT WAS IDENTIFIED FOR THIS LOT, BUT 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. 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. FOR MORE DETAILS SEE THE INFORMATION UNDER THE CHILD INV 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 INFUSION SET LEAKAGE EVENT ON (B)(6) 2025. THE TUBING WAS KINKED WHERE THE TUBING AND NEEDLE MEET. THE PATIENT FACED THIS ISSUE WITH 3 INFUSION SETS. THE INFUSION SET WAS IN USE FOR ONE DAY. THE PATIENT HAD TO VISIT EMERGENCY ROOM ON (B)(6) 2025. THE HIGHEST BLOOD GLUCOSE LEVEL RELATED TO THIS EVENT WAS 500 MG/DL. THE PATIENT GOT TREATED WITH INTRAVENOUS (IV) AND FLUIDS SALINE AND INSULIN AND ZOFRAN. THE PATIENT WAS FOUND POSITIVE FOR HIGH KETONES LEVEL. THE LENGTH OF HOSPITALIZATION WAS 6 HOURS. 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
    2753643 INSET UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001680 6012424 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Required Intervention