BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 24187336 · Received January 27, 2026

    Report

    Report Number
    3003442380-2026-00130
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    January 3, 2026
    Report Date
    February 6, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018051
    PMA / PMN Number
    K070430
    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: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 05-FEB-2026 AGAINST "LOT NUMBER 6010425 AND SIMILAR MALFUNCTION CODES: CLINICAL HISTORY NON-PRODUCT EVENT. NON PRODUCT RELATED EVENT DUE TO PRIOR CLINICAL CIRCUMSTANCES, IMPROPER PRODUCT SELECTION/TREATMENT METHOD, ACCORDING TO CLINICAL HISTORY OF THE COSTUMER (E.G., HISTORY OF ALLERGIC REACTIONS, CONTINUING USE DESPITE KNOWN ISSUES WHEN USING THE SET). THE REVIEW CONFIRMED THAT LOT 6010425 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 29-DEC-2025 AGAINST "LOT NUMBER" CRITERIA EQUAL 6010425 AND SIMILAR MALFUNCTION CODES CLINICAL HISTORY NON-PRODUCT EVENT. NON PRODUCT RELATED EVENT DUE TO PRIOR CLINICAL CIRCUMSTANCES, IMPROPER PRODUCT SELECTION/TREATMENT METHOD, ACCORDING TO CLINICAL HISTORY OF THE COSTUMER (E.G., HISTORY OF ALLERGIC REACTIONS, CONTINUING USE DESPITE KNOWN ISSUES WHEN USING THE SET). THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBERS ARE (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010425 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MACHINE MULTIVAC 12 ON 29-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY: THE LOT 4L03320 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 29-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L06312 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 30-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES. ALL REQUIRED IN-PROCESS AND FINAL TESTS WERE COMPLETED AND MET SPECIFIED REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED THAT RELATE 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 PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 19-NOV-2025. WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 10 SAMPLES OUT 10 TESTED PASSED VISUAL INSPECTION. WI GUIDANCE FOR FUNCTIONAL TESTING 1 AIR FLOW TEST FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 TESTED PASSED FUNCTIONAL TESTING FOR THE REPORTED MALFUNCTION CODE CLINICAL HISTORY NON-PRODUCT EVENT 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 6010425 AND RELATED MALFUNCTION CODES. ONE COMPLAINT WAS 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

    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 SAUDI ARABIA. IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED (B)(6) 2026 DUE TO BENT CANNULA.THE ISSUE OCCURRED BECAUSE SUFFICIENT SUBCUTANEOUS TISSUE WAS NOT FOUND AT THE INSERTION SITE, LEADING TO HYPERGLYCAEMIA.THE INSERTION SITE WAS ABDOMEN. THE BLOOD GLUCOSE LEVEL WAS 366 MG/DL AT THE TIME ADMITTED TO HOSPITAL OF AND THE PATIENT GOT TREATED WITH INTRAVENOUS INSULIN. THE LENGTH OF HOSPITALIZATION STAY WAS FOR LESS THAN 24HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249293 QUICK SET UNO QUICK-SET 110/9 SC1 MECA FPA UNOMEDICAL UM-D MMT-396A 6010425 05705244018051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention