BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23507746 · Received November 10, 2025

    Report

    Report Number
    3003442380-2025-15978
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 5, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244019287
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES. 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 6010605, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: PENDIENTE A QUERY WAS RUN ON 04-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL #6010605. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR)REVIEW: THE LOT 6010605 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 99 AND MANUFACTURED IN THE MULTIVAC M14 ON 12-DIC-2024, WITH A TOTAL OF (B)(4) UNITS. THE WELDING LOT 4M02431 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 34 AND MANUFACTURED IN THE LINE LS24 - LS25, ON 11-DIC-2024, WITH A TOTAL OF (B)(4) UNITS. THE WELDING LOT 4M01484 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 34 AND MANUFACTURED IN THE LINE LS24 - LS25, ON 10-DIC-2024, WITH A TOTAL OF (B)(4) UNITS. THE WELDING LOT 4C04934 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 34 AND MANUFACTURED IN THE LINE LS24 - LS25, ON 10-DIC-2024, WITH A TOTAL OF (B)(4) UNITS THE GLUING CONNECTOR LOT 4M01470 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 37 AND MANUFACTURED IN THE GLUING LINE 3, ON 10-DIC-2024, WITH A TOTAL OF (B)(4) UNITS. THE GLUING CONNECTOR LOT 4M01471 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 37 AND MANUFACTURED IN THE GLUING LINE 3, ON 10-DIC-2024, WITH A TOTAL OF (B)(4) UNITS. THE GLUING CONNECTOR LOT 4M01482 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 37 AND MANUFACTURED IN THE GLUING LINE 3, ON 11-DIC-2024, WITH A TOTAL OF (B)(4) UNITS. THE GLUING CONNECTOR LOT 4M02614 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 37 AND MANUFACTURED IN THE GLUING LINE 3, ON 12-DIC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 4M01988 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 65 AND MANUFACTURED IN THE GLUING MACHINE SC05 - SC06, ON 11-DIC-2024, 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. TEST RESULTS: NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED. IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE(S) FROM THE LOT HAVE BEEN REQUESTED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TEST FOR COMPLAINTS AREA VERSION 3: ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. WORK INSTRUCTION (WI) GUIDANCE FOR FUNCTIONAL TESTING 1 AIR FLOW TEST FOR COMPLAINTS AREA VERSION 2: ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. WORK INSTRUCTION (WI) GUIDANCE FOR FUNCTIONAL TESTING 2 AIR LEAK TEST FOR COMPLAINTS AREA VERSION 2: ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, 1 COMPLAINT IN THRESHOLDS IDENTIFIED FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, 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

    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 6010605 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: PENDIENTE A QUERY WAS RUN ON 04-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL 6010605. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010605 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 99 AND MANUFACTURED IN THE MULTIVAC M14 ON 12-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE WELDING LOT 4M02431 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 34 AND MANUFACTURED IN THE LINE LS24 - LS25, ON 11-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE WELDING LOT 4M01484 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 34 AND MANUFACTURED IN THE LINE LS24 - LS25, ON 10-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE WELDING LOT 4C04934 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 34 AND MANUFACTURED IN THE LINE LS24 - LS25, ON 10-DEC-2024, WITH A TOTAL OF (B)(4) UNITS THE GLUING CONNECTOR LOT 4M01470 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 37 AND MANUFACTURED IN THE GLUING LINE 3, ON 10-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE GLUING CONNECTOR LOT 4M01471 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 37 AND MANUFACTURED IN THE GLUING LINE 3, ON 10-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE GLUING CONNECTOR LOT 4M01482 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 37 AND MANUFACTURED IN THE GLUING LINE 3, ON 11-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE GLUING CONNECTOR LOT 4M02614 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 37 AND MANUFACTURED IN THE GLUING LINE 3, ON 12-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 4M01988 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 65 AND MANUFACTURED IN THE GLUING MACHINE SC05 - SC06, ON 11-DEC-2024, WITH A TOTAL OF 30,900 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, 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 THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS 445 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS FLUIDS OF INSULIN. THE PATIENT FACED DIABETIC KETOACIDOSIS EVENT. THE DURATION OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. PATIENT WAS EXPERIENCED THE SYMPTOMS OF FEELING SICK, UNWELL AND INCREASED THIRST. 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
    173766 CONTACT DETACH UNO CONTACT DETACH G29 46/6 SC1 MIMX FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-862A 6010605 05705244019287

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H