BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23713019 · Received December 4, 2025

    Report

    Report Number
    3003442380-2025-17165
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    November 2, 2025
    Report Date
    November 14, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6) PATIENT COUNTRY: TURKEY. 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 6011258, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON (B)(6) 2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL 6011258 THE COUNT OF COMPLAINTS IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011258 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC M12 ON 18-OCT-2024, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 5A02509 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND MANUFACTURED IN THE QUICKSET LINE, ON 21-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 5A03821 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE MP04 - MP08, ON 19-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT A NON-CONFORMANCE (B)(4) WAS OPENED DURING THE STERILIZATION PROCESS (THIS ISSUE IS NOT LINKED TO THE PERFORMANCE OF THE PROCESS), AND FURTHER PRODUCT DISPOSITION WERE REQUIRED. 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. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO DEFECT ON TESTS FOR REFERENCE SAMPLES, ONE NON-CONFORMANCE (NC) RAISED DURING PRODUCTION UNRELATED 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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN TURKEY. IT WAS REPORTED THAT THE PATIENT FACED BENT CANNULA EVENT ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS HIGH (400 MG/DL) DUE TO WHICH THE PATIENT WENT TO EMERGENCY ROOM ON (B)(6) 2025 FOR LESS THAN TWENTY FOUR HOURS. THE PATIENT WAS TREATED WITH INTRAVENOUS INSULIN DRIP. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979098 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6011258 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention