BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK-SET

    MDR report key: 22724455 · Received August 6, 2025

    Report

    Report Number
    3003442380-2025-12457
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    July 15, 2025
    Report Date
    July 28, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K991759
    Adverse Event
    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. THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6001211 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING OF QUICK SET. THE LOT 6001211 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 75, ON 30/ABR/2024, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY OF QUICK SET: THE LOT 3D03888 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 ASSEMBLED IN THE QUICKSET LINE, ON 26/ABR/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3D03889 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 ASSEMBLED IN THE QUICKSET LINE, ON 27/ABR/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3D03890 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 ASSEMBLED IN THE QUICKSET LINE, ON 28/ABR/2023, 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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 28/JUL/2025 AGAINST MALFUNCTION CODE IDD-PMC05.26 AND LOT 6001211 AND OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE. NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR 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 AN EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS (DKA) EVENT CAUSED BY AN INFUSION SET BENT CANNULA. BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL AT THE TIME OF THE EVENT AND PATIENT GOT TREATED WITH INTRAVENOUS (IV) DRIP. THE DURATION OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. PATIENT WAS EXPERIENCED THE SYMPTOMS OF SICK/UNWELL, INCREASED THIRST, SLURRING WORDS, SHAKING. PATIENT HAD KETONES LEVEL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528021 QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6001211 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R