BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23483356 · Received November 5, 2025

    Report

    Report Number
    3003442380-2025-15861
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 28, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018488
    PMA / PMN Number
    K041545
    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. COMPLAINT INVESTIGATION RESULTS: THE BATCH 6003436, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. A COMPLAINT INVESTIGATION HAS BEEN INITIATED TO REVIEW THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH THE REPORTED ISSUE. DHR REVIEW: THE LOT 6003436 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 94.0, IN THE MULTIVAC M10, ON 26/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: WELDING THE LOT 3J03235 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 32.0 WELDING IN THE MACHINE LS24-LS25-LS11, ON 24/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING THE LOT 3J03254 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 55.0 AND MANUFACTURED IN THE LINE SPOT 05-06, ON 24/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF CONNECTOR THE LOT 3J03223 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 35.0 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 24/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3J02652 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 35.0 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 22/SEP/2023, 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. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS AT THE SITE. THE PATIENT CHANGED SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. THE BLOOD GLUCOSE LEVELS WAS HIGH AND PATIENT WAS TREATED WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTIONS. 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
    2478501 CONTACT DETACH UNO CONTACT DETACH G29 60/8TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002835 6003436 05705244018488

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female