BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTACT DETACH

    MDR report key: 23460199 · Received November 3, 2025

    Report

    Report Number
    3003442380-2025-15761
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 22, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL (B)(4) - DEVICE 4 OF 4. 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 6013717, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 22-OCT-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL #6013717. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013717 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND MANUFACTURED IN THE LINE M14 ON 11-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE WELDING LOT # 5E04018 WAS MANUFACTURED ACCORDING TO THE (B)(4) VERSION 34 AND MANUFACTURED IN THE LINE L506-L507, ON 08-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE WELDING LOT 5E04009 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE LINE L524-L525, ON 08-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE WELDING LOT 5E03376 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE LINE L511, ON 01-JUN-2025, WITH A TOTAL OF (B)(4) UNITS THE GLUING CONNECTOR LOT 5E02180 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING LINE 3, ON 08-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE GLUING CONNECTOR LOT 5E02182 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING LINE 3, ON 08-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE GLUING CONNECTOR LOT 5F01649 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING LINE 3, ON 08-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE GLUING CONNECTOR LOT 5E02165 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING LINE 3, ON 29-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE GLUING CONNECTOR LOT 5E02174 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING LINE 3, ON 05-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE GLUING CONNECTOR LOT 5F01650 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING LINE 3, ON 10-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE GLUING CONNECTOR LOT 5F02586 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING LINE 3, ON 14-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE GLUING CONNECTOR LOT 5F03092 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING LINE 3, ON 15-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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: WI GUIDANCE FOR VISUAL TEST FOR COMPLAINTS AREA VERSION 3: ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. 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. 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. 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 WAS HOSPITALIZED DUE TO INFUSION SET LEAKAGE LEADING TO HYPERGLYCEMIA ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS 600 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. THE INFUSION SET WAS IN USE FOR 18 HOURS. THE LENGTH OF HOSPITALIZATION WAS 5.5 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686930 CONTACT DETACH UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002833 6013717 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention