BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 22779761 · Received August 11, 2025

    Report

    Report Number
    3003442380-2025-12713
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 28, 2025
    Report Date
    October 14, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018488
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4. 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: REVISION 21 OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4) THE BATCH 6011679, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011679 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 100 AND PACKAGING IN THE MACHINE MULTIVAC 14 ON 17-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBE OF THE LOT 5B00058 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66 AND MANUFACTURED IN THE MACHINE SC06-SC05 ON 16-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBE OF THE LOT 5A04167 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66 AND MANUFACTURED IN THE MACHINE SC08 ON 14-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT A ONE NON-CONFORMANCE (NC) 2165520 WAS RAISED DURING THE STERILIZATION PROCESS. THIS ONE NON-CONFORMANCE (NC) IS NOT RELATED TO CLAIMED MALFUNCTION. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: ONE NON-CONFORMANCE (NC) WAS RAISED DURING THE STERILIZATION PROCESS, AND FOUND UNRELATED TO THE REPORTED 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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. PATIENT CHANGED SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339632 CONTACT DETACH UNO CONTACT DETACH G29 60/8TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002835 6011679 05705244018488

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female