BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23388344 · Received October 27, 2025

    Report

    Report Number
    3003442380-2025-15345
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    September 26, 2025
    Report Date
    November 5, 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

    INITIAL AND FINAL MDR (B)(4) - MDR -3003442380-2025-15345 - DEVICE 1 OF 2.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2025-15345. THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2025-15345), WAS SUBMITTED ON 27-OCT-2025. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 09-FEB-2025. 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 6011597 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011597 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 100 AND PACKAGING IN THE MULTIVAC 14, ON 09/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING THE LOT 5A04046 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 WELDING IN THE MACHINE LS24 & LS25, ON 17/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR THE LOT WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 17/JUN/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 ITALY IT WAS REPORTED THAT THE PATIENT FACED CANNULA BENT EVENT ON (B)(6) 2025. THE PATIENT NOTICED SYMPTOMS WITHIN 3 OR MORE HOURS OF INSERTION. THE INFUSION SET WAS IN USE FOR FEW HOURS. THE SITE OF INSERTION WAS ABDOMEN. THE PATIENT FACED INFUSION SET ISSUE WITH 2 SETS. THE PATIENT RESOLVED THE ISSUE BY REPLACING 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
    2793503 CONTACT DETACH UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002833 6011597 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown