BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23355582 · Received October 22, 2025

    Report

    Report Number
    3003442380-2025-15134
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 23, 2025
    Report Date
    November 5, 2025
    Manufacturer
    UNOMEDICAL 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 6013794 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013794 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

    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 DID NOT REMOVE THE NEEDLE GUARD BEFORE INSERTING NEW INFUSION SET DURING SITE CHANGE EVENT ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS 470 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH CORRECTION BOLUS VIA PUMP. 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
    232119 CONTACT DETACH UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL S.A DE C.V 1002833 6013794 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female