BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23590146 · Received November 18, 2025

    Report

    Report Number
    3003442380-2025-16773
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    November 1, 2025
    Report Date
    November 27, 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 TO REVIEW THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH THE REPORTED ISSUE. THE BATCH 6012371 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DHR REVIEW: THE LOT 6012371 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND PACKAGING IN THE MULTIVAC 14, ON 17-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING: THE LOT 5B03048 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34.0 WELDING IN THE MACHINE LS24, AND LS25 ON 15/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR: THE LOT 5C01369 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 14/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5C01370 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 15/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, MOULDING: THE LOT 5B05913 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE MOULDING IN THE LINE LS14 ON 28/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B05916 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE MOULDING IN THE LINE LS19 ON 10/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B02896 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE MOULDING IN THE LINE LS19 ON 14/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B05920 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE MOULDING IN THE LINE LS18 ON 13/MAR/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 THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS AT THE SITE. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    495445 CONTACT DETACH UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL S.A DE C.V 1002833 6012371 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male