BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23540457 · Received November 13, 2025

    Report

    Report Number
    3003442380-2025-16370
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    October 25, 2025
    Report Date
    November 12, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018051
    PMA / PMN Number
    K160648
    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 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 6011270, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 09-OCT-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6011270". THE COUNT COMPLAINT IS WHICH IS EXCEEDS 4. FURTHER INVESTIGATION IS REQUIRED VIA CAPA DETERMINATION ASSESSMENT USING STATISTICAL ANALYSIS. THE COMPLAINT NUMBERS ARE: (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011270 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC 12, ON 25-JAN-2025 WITH A TOTAL OF (B)(4) UNITS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. TEST RESULTS: PHOTO/SAMPLE WAS NOT PROVIDED. NO RETURNED SAMPLE WILL BE AVAILABLE FOR THIS COMPLAINT, THE REFERENCE SAMPLES FOR THE LOT 6011270 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 08-OCT- 2025. REFERENCES SAMPLES: VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 3.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WORK INSTRUCTION (WI) VERSION 2.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO NON CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, FOUR 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 CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT.

    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 6011270, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 09-OCT-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6011270". THE COUNT COMPLAINT IS WHICH IS EXCEEDS 4. FURTHER INVESTIGATION IS REQUIRED VIA CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT USING STATISTICAL ANALYSIS. THE COMPLAINT NUMBERS ARE: (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011270 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC 12, ON 25-JAN-2025 WITH A TOTAL OF (B)(4) UNITS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. TEST RESULTS: PHOTO/SAMPLE WAS NOT PROVIDED. NO RETURNED SAMPLE WILL BE AVAILABLE FOR THIS COMPLAINT, THE REFERENCE SAMPLES FOR THE LOT 6011270 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 08-OCT- 2025. REFERENCES SAMPLES: VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 3.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WORK INSTRUCTION (WI) VERSION 2.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, FOUR 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 CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT WENT TO AN EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA EVENT CAUSED BY BENT CANNULA. BLOOD GLUCOSE LEVEL WAS 380 MG/DL AT THE TIME OF THE EVENT AND PATIENT GOT TREATED WITH INSULIN PENS. THE DURATION OF HOSPITALIZATION WAS LESS THAN 24 HOURS. PATIENT ALSO EXPERIENCED THE SYMPTOMS OF VOMITING, AND CONFUSION. 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
    2119045 QUICK SET UNO QUICK-SET 110/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-396A 6011270 05705244018051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention