BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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    MDR report key: 23034938 · Received September 12, 2025

    Report

    Report Number
    3003442380-2025-13638
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 15, 2025
    Report Date
    October 3, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018426
    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: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6013003, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013003 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND PACKAGING IN THE MULTIVAC M14 ON 25-APR-2025, WITH A TOTAL OF (B)(4) UNITS. AN EXTENDED FOR LOOSE CONTAMINATION WAS PERFORMED FOR THE OUTGOING TEST 6(G). THE SUB-ASSEMBLY: GLUING CONNECTOR OF THE LOT 5D03559 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE MACHINE L3, ON 23-APR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING CONNECTOR OF THE LOT 5D02708 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE MACHINE L3, ON 23-APR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING CONNECTOR OF THE LOT 5D02707 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE MACHINE L3, ON 23-APR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING CONNECTOR OF THE LOT 5D03560 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE MACHINE L3, ON 24-APR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING CONNECTOR OF THE LOT 5D03697 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE MACHINE L7, ON 22-APR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING CONNECTOR OF THE LOT 5D02708 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE MACHINE L3, ON 23-APR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING CONNECTOR OF THE LOT 5D03560 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE MACHINE L3, ON 24-APR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING CONNECTOR OF THE LOT 5C02213 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE MACHINE L7, ON 15-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING CONNECTOR OF THE LOT 5D03561 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE MACHINE L3, ON 25-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. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: ONE EXTENDED WAS RAISED DURING THE PROCESS UNRELATED TO THE MALFUNCTION REPORTED, THEREFORE, NO NON-CONFORMANCE (NC) RAISED RELATED TO COMPLAINT 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

    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 FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS AT THE SITE. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233164 CONTACT DETACH UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002833 6013003 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female