BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23565970 · Received November 16, 2025

    Report

    Report Number
    3003442380-2025-16427
    Event Type
    Malfunction
    Date Received
    November 16, 2025
    Date of Event
    October 23, 2025
    Report Date
    November 28, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V
    Product Code
    FPA
    UDI-DI
    05705244019317
    PMA / PMN Number
    K160648
    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

    SUPPLEMENTAL REPORT 01 - MDR (B)(4) - MDR 3003442380-2025-16427. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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: 6012695, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT: 6012695 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101.0, IN THE MULTIVAC 10, ON 08/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING. THE LOT: 5D04840 WAS MANUFACTURED ACCORDING TO THE WI VERSION 67.0 AND MANUFACTURED IN THE LINE FT02, ON 09/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT: 5B04497 WAS MANUFACTURED ACCORDING TO THE WI VERSION 67.0 AND MANUFACTURED IN THE LINE FT02, ON 25/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT: 5D04841 WAS MANUFACTURED ACCORDING TO THE WI VERSION 67.0 AND MANUFACTURED IN THE LINE FT02, ON 11/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT: 5B04499 WAS MANUFACTURED ACCORDING TO THE WI VERSION 67.0 AND MANUFACTURED IN THE LINE FT02, ON 16/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF CONNECTOR THE LOT: 5C04822 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39.0 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 24/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT: 5D03572 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39.0 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 04/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT: 5D03574 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39.0 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 05/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT: 5D03575 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39.0 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 07/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT: 5D03700 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39.0 IN THE GLUING OF CONNECTOR IN THE LINE 07, ON 03/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT: 5D04878 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39.0 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 06/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT: 5D04881 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39.0 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 09/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT: 5E02183 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39.0 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 10/MAY/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. NOTE: EXTENDED BY 2D CODE FAILURE. 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.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(4). PATIENT COUNTRY: CANADA.

    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). THE EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2858980 CONTACT DETACH UNO CONTACT DETACH G29 60/6 SC1 MIMX FPA UNOMEDICAL DEVICES S.A. DE C.V MMT-864A 6012695 05705244019317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown