BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23530270 · Received November 12, 2025

    Report

    Report Number
    3003442380-2025-16027
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 19, 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
    003

    Narratives

    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 6001424 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 18-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL 6001424 THE COUNT OF COMPLAINTS IS 8 WHICH IS ABOVE 3. FURTHER INVESTIGATION IS REQUIRED VIA CAPA DETERMINATION ASSESSMENT USING STATISTICAL ANALYSIS. THE COMPLAINT NUMBERS ARE: (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001424 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 75 AND MANUFACTURED IN THE MULTIVAC 12 ON 26-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 3E04094 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE QUICKSET LINE, ON 25-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 3E04095 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE QUICKSET LINE, ON 25-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT A NON-CONFORMANCE (NC) 1674558 WAS OPENED DURING THE STERILIZATION PROCESS (THE ISSUE IS RELATED TO STERIGENICS GRAND PRAIRIE STERILIZATION SUPPLIER. WHICH IS NOT LINKED TO THE PERFORMANCE OF THE PROCESS), AND FURTHER PRODUCT DISPOSITION WERE REQUIRED. TEST RESULTS: IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE(S) FROM THE LOT HAVE BEEN REQUESTED. NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED. THE REFERENCE SAMPLES WERE ALREADY TESTED IN THE COMPLAINT (B)(4). 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, ONE NC RAISED DURING PRODUCTION UNRELATED TO COMPLAINT CODE, THE THRESHOLDS OF 8 REPORTABLE COMPLAINTS ARE MET FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT REQUIRES FURTHER CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT.

    Additional Manufacturer Narrative · 0

    PATIENT CITY: (B)(6) PATIENT COUNTRY : UNITED ARAB EMIRATES.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EVENT IN WHICH INFUSION SET CANNULA WAS BENT ON (B)(6) 2025. LATER, THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED FOR LESS THAN 24 HOURS DUE TO HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE LEVELS WAS 500MG/DL AT THE TIME OF EVENT AND HAD KETONES WITH VALUE 2MMOL/L. THE PATIENT RECEIVED INTRAVENOUS INSULIN DRIP AS A CORRECTIVE TREATMENT. PATIENT ALSO EXPERIENCED SYMPTOMS LIKE DIZZINESS AND TIRED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594717 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6001424 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention