BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23232472 · Received October 7, 2025

    Report

    Report Number
    3003442380-2025-14529
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 6, 2025
    Report Date
    November 5, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V
    Product Code
    FPA
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 6013794 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DHR REVIEW: THE LOT 6007858 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND PACKAGING IN THE MULTIVAC 14, ON 18/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING THE LOT 5F03350 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 34 WELDING IN THE MACHINE LS24 & LS25, ON 17/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING THE LOT 5F02550 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 34 WELDING IN THE MACHINE LS06 & LS07, ON 15/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING THE LOT 5F02571 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 34 WELDING IN THE MACHINE LS06 & LS07, ON 16/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR THE LOT 5F03358 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 40 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 17/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR THE LOT 5F03359 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 40 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 18/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR THE LOT 5F02586 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 40 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 14/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR THE LOT 5F03094 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 40 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 16/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR THE LOT 5F03093 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 40 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 16/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR THE LOT 5F03092 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 40 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 15/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR THE LOT 5F03091 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 40 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 15/JUN/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: 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, PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. THE SITE OF INSERTION WAS ABDOMEN, MOST RECENT IN ARMS. 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
    1438938 CONTACT DETACH UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V 1002833 6013794

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female