BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23001049 · Received September 9, 2025

    Report

    Report Number
    3003442380-2025-13512
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 11, 2025
    Report Date
    October 13, 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

    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: REVISION 21 OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4) THE BATCH 6012846, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012846 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND PACKAGING IN THE MACHINE MULTIVAC 14 ON 13-APR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING OF THE LOT 5D01362 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE MACHINE LS24-LS25, ON 12-APR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 5D01336 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 12-APR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 5D02703 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 12-APR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 5D02704 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 12-APR-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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 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 11-AUG-2025. THE BLOCKAGE WAS AT THE SITE. THE BLOOD GLUCOSE LEVELS WAS HIGH AND THE PATIENT TREATED WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION (MDI). THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067879 CONTACT DETACH UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002833 6012846 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female