BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23529232 · Received November 11, 2025

    Report

    Report Number
    3003442380-2025-16023
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    October 15, 2025
    Report Date
    October 17, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED ARAB EMIRATES. 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 6001424, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 31-OCT-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6001424". IF THE COUNT OF COMPLAINTS EQUALS OR EXCEEDS 8, FURTHER INVESTIGATION IS REQUIRED VIA CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT USING STATISTICAL ANALYSIS. THE COMPLAINT NUMBERS ARE: (B)(4). DHR REVIEW: THE LOT 6001424 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 75 PACKING IN THE MULTIVAC 12, ON 26/MAY/2024, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING: THE LOT 3E04443 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE MACHINE 08, ON 24/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E04442 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE MACHINE 05, ON 24/JAN/2023, WITH A TOTAL OF (B)(4) UNITS. NON-CONFORMANCE (NC) (B)(4) SUPPLIER. NO RELATION WITH MALFUNCTION CODE. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TEST RESULTS: NO PHOTO WAS PROVIDED. THE REFERENCE SAMPLES FOR THE LOT 6001424 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 12-FEB- 2025. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST AND WI GUIDANCE FOR FUNCTIONAL FLOW TESTING FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST FOR THE CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO NC RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, EIGHT COMPLAINTS THRESHOLDS IDENTIFIED FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, NO FURTHER ACTIONS ARE REQUIRED ARE MET FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT REQUIRES FURTHER CAPA DETERMINATION ASSESSMENT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT FACED BENT CANNULA WHICH LED TO HIGH BLOOD GLUCOSE LEVEL. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF HOSPITALIZATION AND INSULIN WAS ADMINISTERED VIA INTRAVENOUS DRIP IN THE HOSPITAL. THE DURATION OF HOSPITALIZATION WAS LESS THAN 24 HOURS. PATIENT ALSO EXPERIENCED THE SYMPTOMS OF VOMITING, HEADACHE AND DIZZINESS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2543838 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 6001424 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention