BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23376611 · Received October 24, 2025

    Report

    Report Number
    3003442380-2025-15211
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    August 23, 2025
    Report Date
    October 23, 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: PORTUGAL.

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER, WAS SUBMITTED ON 24-OCT-2025. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 22-OCT-2024. 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 - A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6010399, IN QUESTION WAS MANUFACTURED AT THE: REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 21-OCT-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6010399". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010399 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC 12 ON 22-OCT-2024, 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, HOWEVER, DURING THE FINAL OUTGOING INSPECTION, TEST NUM 9, A DELAMINATION WAS FOUND, AN EXPANDED SAMPLING PLAN WAS PERFORMED WHICH DETERMINED THAT IT WAS WITHIN SPECIFICATIONS AND MET THE REQUIREMENTS. A NON-CONFORMANCE NC (B)(4) WAS OPENED DURING STERILIZATION PROCESS, STERILIZATION SUPPLIER SELECTED INCORRECT AERATION TIME FOR LOAD (B)(4). THE OVERALL PRODUCT RISK LEVEL IS SET AS LOW, AS NO IMPACT ON THE PRODUCT WAS IDENTIFIED, DESPITE THE EVENT BEING RELATED TO THE PRODUCT. THEREFORE, NO NEGATIVE IMPACT ON THE FINAL PRODUCT CAN BE IDENTIFIED, EITHER IN TERMS OF FIT, FORM, OR FUNCTION FOR THE END USER. THE SUB-ASSEMBLY: THE LOT 4L03182 WAS ASSEMBLED ACCORDING TO THE WI VERSION 27 AND MANUFACTURED ON 21-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L03183 WAS ASSEMBLED ACCORDING TO THE WI VERSION 27 AND MANUFACTURED ON 21-NOV-2024, 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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. GLUING OF TUBING OF THE LOT 4L01866 MANUFACTURED IN THE AUTOMATIC GLUING MACHINE 04, 05 AND 08, ON 16-NOV-2024, 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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: IN ORDER TO TEST THE PRODUCT, NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED, THEREFORE, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST AIR FLOW ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST, FOR THE CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO DEFECT ON TEST OF REFERENCE SAMPLES. A SAMPLING PLAN EXTENDED WAS PERFORMED DURING FINAL INSPECTION OUTGOING PROCESS NO RELATED TO COMPLAINT CODE, ONE NC RAISED DURING STERILIZATION PROCESS NO RELATED TO COMPLAINT CODE, NO 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 PORTUGAL. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT OF HIGH BLOOD GLUCOSE ON (B)(6) 2025. THE PATIENT WAS TIRED, WEAK. THE PATIENT WAS HOPITALIZED FOR LESS THAN TWEMTY-FOUR HOURS ON (B)(6) 2025 WITH BLOOD GLUCOSE OF 207 MG/DL. THE PATIENT WAS TREATED WITH INSULIN PEN. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603160 QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6010399 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention