BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23578539 · Received November 18, 2025

    Report

    Report Number
    3003442380-2025-16553
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    July 30, 2025
    Report Date
    November 19, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017931
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED MANUFACTURING DATE UNDER D4 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 6011997, IN QUESTION WAS MANUFACTURED AT THE: REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 13-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH" , "LOT NUMBER" CRITERIA EQUAL "6011997" . THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011997 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC 12 ON 08-MAR-2025, WITH A TOTAL OF 28,500 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. THE SUB-ASSEMBLY: THE LOT 5C00039 WAS ASSEMBLED ACCORDING TO THE WI VERSION 29 AND MANUFACTURED ON 08-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5C00040 WAS ASSEMBLED ACCORDING TO THE WI VERSION 29 AND MANUFACTURED ON 08-MAR-2025, 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 5B04423 MANUFACTURED IN THE MACHINE MP08, ON 21-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING OF THE LOT 5B04988 MANUFACTURED IN THE MACHINE MP04, MP08, ON 07-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING OF THE LOT 5B04990 MANUFACTURED IN THE MACHINE MP04, MP08, ON 07-MAR-2025, 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. 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 TESTING FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST FOR THE CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT 2441553. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO DEFECT ON TEST OF REFERENCE SAMPLES., NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION 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.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.

    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 STATES. IT WAS REPORTED THAT THE PATIENT FACED A BENT CANNULA EVENT ON (B)(6) 2025 WHICH LED TO HIGH BLOOD GLUCOSE LEVEL. THE INSERTION SITE WAS ABDOMEN. THE INFUSION SET WAS IN USE FOR 2-3 DAY. THE PATIENT ADMITTED TO EMERGENCY ROOM WITH HIGH BLOOD GLUCOSE LEVEL WAS 700 MG/DL. DUE TO HIGH BLOOD GLUCOSE LEVEL PATIENT EXPERIENCED INCREASED THIRST, VOMITING. DURING HOSPITALIZATION, THE PATIENT RECEIVED INSULIN INTRAVENOUSLY AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE LENGTH OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643950 QUICK SET UNO QUICK-SET 110/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-398A 6011997 05705244017931

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H