BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23494289 · Received November 7, 2025

    Report

    Report Number
    3003442380-2025-15864
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 26, 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 TO REVIEW THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH THE REPORTED ISSUE. THE BATCH 6011321, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THE LOT 6011321 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 100 AND PACKAGING IN THE MULTIVAC 14, ON 28/JAN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING THE LOT 5A02603 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 66 AND MANUFACTURED IN THE SC07, ON 24-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4M03293 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 66 AND MANUFACTURED IN THE SC08, ON 19-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING THE LOT 5A04030 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 34 WELDING IN THE MACHINE LS24, AND LS25, ON 25/JAN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR THE LOT 4M03218 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 37 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 25/JAN/2025, WITH A TOTAL OF (B)(4) UNITS THE LOT 5A04030 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 34 IN THE GLUING OF CONNECTOR IN THE LINE LS24, AND LS25, ON 25/JAN/2025, WITH A TOTAL OF (B)(4) UNITS THE LOT 4M03219 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 37 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 26/JAN/2025, WITH A TOTAL OF (B)(4) UNITS 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 GERMANY 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622762 CONTACT DETACH UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002833 6011321 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown