BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 24301279 · Received February 10, 2026

    Report

    Report Number
    3003442380-2026-00383
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    January 15, 2026
    Report Date
    January 20, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Product Problem
    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: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH A QUERY WAS RUN IN THE EQMS ON (B)(6) 2026 AGAINST "LOT NUMBER 6010576 AND SIMILAR MALFUNCTION CODES: SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE. SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA AND INTRODUCER NEEDLE FOUND BENT/KINKED DURING INSERTION, UNABLE TO USE, SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE. THE REVIEW CONFIRMED THAT LOT 6010576 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON (B)(6) 2026 AGAINST "LOT NUMBER" CRITERIA EQUAL (B)(4) AND SIMILAR MALFUNCTION CODES SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE. SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA AND INTRODUCER NEEDLE FOUND BENT/KINKED DURING INSERTION, UNABLE TO USE, SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE. THE COUNT OF COMPLAINTS IS 2. THE COMPLAINT NUMBERS ARE COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010576 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC M12, ON 09-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY LOT 4L04948 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND MANUFACTURED IN THE QUICKSET LINE, ON 09-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY LOT 4L04949 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND MANUFACTURED IN THE QUICKSET LINE, ON 09-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY LOT 4L04950 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND MANUFACTURED IN THE QUICKSET LINE, ON 09-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE DHR REVIEW INDICATED THAT DURING OUTGOING TEST 9 (OTHERS), ONE SAMPLE WAS FOUND WITH RELEASE LINER DELAMINATES FROM ADHESIVE PATCH. AN EXTENDED SAMPLING WAS CONDUCTED AND ACCEPTED IN ACCORDANCE WITH ESTABLISHED PROCEDURES. THEREFORE, THE OVERALL REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED IN RELATION TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; NO ISSUES NOTED. VISUAL EVIDENCE REVIEW: NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. RETAIN SAMPLES TESTING: RETAIN SAMPLES FROM THE RELEVANT LOT WERE REQUESTED AND TESTED IN ACCORDANCE WITH APPROVED PROCEDURES: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: ALL 3 SAMPLES TESTED PASSED VISUAL INSPECTION. WI GUIDANCE FOR FUNCTIONAL TESTING 1 AIR FLOW TEST FOR COMPLAINTS AREA VERSION 2: ALL 3 SAMPLES TESTED PASSED FUNCTIONAL TESTING FOR THE REPORTED MALFUNCTION CODE SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE. ALL TEST RESULTS WERE WITHIN SPECIFICATION AS DOCUMENTED IN THE ATTACHED TEST REPORT COMPLAINT (B)(4). CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EQMS QUERIES, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD REVIEW, VISUAL EVIDENCE ASSESSMENT, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6010576 AND RELATED MALFUNCTION CODES. TWO COMPLAINTS WERE IDENTIFIED FOR THIS LOT; HOWEVER, NO TREND OR SYSTEMIC ISSUE WAS DETECTED. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. SAMPLES WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT NO SAMPLES WERE AVAILABLE FOR ANALYSIS. CONSEQUENTLY, AN INVESTIGATION WAS CONDUCTED USING REFERENCE SAMPLES, AND NO FAILURES RELATED TO THE COMPLAINT WERE IDENTIFIED. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION AND REFERENCE SAMPLE ANALYSIS ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN BRAZIL. IT WAS REPORTED THAT PATIENT FACED INFUSION SET BENT CANNULA EVENT DUE TO WHICH THE PATIENT FACED HYPERGLYCEMIA EVENT ON (B)(6) 2026. THE PATIENT WAS HOSPITALIZED AND EVENTUALLY SHIFTED TO INTENSIVE CARE UNIT (ICU). PATIENT EXPERIENCED THE SYMPTOMS OF CHEST PAIN AND MENTAL CONFUSION AT THE TIME OF THE EVENT. THE DURATION OF HOSPITALIZATION WAS OVERNIGHT STAY. THE PATIENT BLOOD GLUCOSE WAS 715 MMOL/DL AND GOT TREATED WITH INTRAVENOUS INSULIN AND 4 BAGS OF SALINE SOLUTION AND USE OF PEN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366592 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6010576 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention