BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23567329 · Received November 17, 2025

    Report

    Report Number
    3003442380-2025-16486
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 27, 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
    MA, 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 6012687, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012687 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 101.0, IN THE MULTIVAC M14, ON 28/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: WELDING THE LOT 5E04014 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 34.0 WELDING IN THE MACHINE LS24-LS25, ON 26/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E04013 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 34.0 WELDING IN THE MACHINE LS24-LS25, ON 25/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E03375 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 34.0 WELDING IN THE MACHINE LS06-LS07, ON 25/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E03372 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 34.0 WELDING IN THE MACHINE LS11, ON 18/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. 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 PATIENT FACED INFUSION SET NEEDLE WAS BENT EVENT ON (B)(6) 2025. THE BLOOD GLUCOSE LEVELS WAS HIGH 286 MG/DL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2875064 CONTACT DETACH UNO CONTACT DETACH G29 60/6 BETA FPA UNOMEDICAL DEVICES S.A. DE C.V. FG000016-03 6012687 05705244025288

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown