BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23540226 · Received November 13, 2025

    Report

    Report Number
    3003442380-2025-16303
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    August 18, 2025
    Report Date
    November 26, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244025288
    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: A COMPLAINT INVESTIGATION HAS BEEN INITIATED TO REVIEW THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH THE REPORTED ISSUE. THE BATCH 6012208, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012208 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 101.0, IN THE MULTIVAC M14, ON 23/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: WELDING THE LOT 5B03037 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 34.0 WELDING IN THE MACHINE LS06-LS07, ON 06/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B03042 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 34.0 WELDING IN THE MACHINE LS24-LS25, ON 10/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING THE LOT 5B05940 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 67.0 AND MANUFACTURED IN THE LINE SC05-SC06, ON 09/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF CONNECTOR THE LOT 5B02935 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 38.0 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 06/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B02936 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 38.0 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 06/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B02937 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 38.0 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 07/MAR2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5C01350 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 38.0 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 08/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5C01351 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 38.0 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 09/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5C01362 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 38.0 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 10/MAR/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, ONE OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION, HARM CODE AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION OR 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 EXPERIENCED AN EVENT IN WHICH INFUSION SET TUBING WAS BENT ON (B)(6) 2025. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2119038 CONTACT DETACH UNO CONTACT DETACH G29 60/6 BETA FPA UNOMEDICAL DEVICES S.A. DE C.V. FG000016-03 6012208 05705244025288

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown