BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 24711377 · Received March 30, 2026

    Report

    Report Number
    3003442380-2026-99748
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 3, 2024
    Report Date
    February 25, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNOMEDICAL HEREBY SUBMITS THIS INITIAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CORRECTIVE AND PREVENTIVE ACTION (CAPA)/FDA ACTION PLAN. THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS INITIAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAINS UNCHANGED. BASED ON THE REVIEW COMPLETED ON 25-FEB-2026 AND INVESTIGATION COMPLETED ON 18-MAR-2026 THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED AS THE INITIAL REPORT. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR CLICK AND STATIC PULL BASE-CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD 6000331 WAS VERIFIED AND IT WAS FOUND WITHIN SPECIFICATIONS. THIS INVESTIGATION HAS BEEN UPDATED BECAUSE THE MALFUNCTION CODE CHANGED WHICH REQUIRES ADDITIONAL ACTIVITIES NOT INCLUDED IN THE ORIGINAL INVESTIGATION DATED 04-MAR 2024. THE ORIGINAL INVESTIGATION REMAINS VALID AND HAS NOT BEEN MODIFIED. AS PART OF THIS REASSESSMENT, THE FOLLOWING ELEMENTS WERE ADDED TO ALIGN WITH CURRENT INVESTIGATION REQUIREMENTS: COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 17/MAR/2026 AGAINST "LOT NUMBER" "6000331" AND SIMILAR MALFUNCTION CODES: LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS, LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE), TUBING DETACHED FROM TUBING-TUBING CONNECTOR, TUBING CONNECTOR IS CRACKED, SPLIT, DEFORMED, LEAKAGE MAY OCCUR. THE REVIEW CONFIRMED THAT LOT 6000331 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 17/MAR/2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6000331" AND SIMILAR MALFUNCTION CODES:LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS, LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE), TUBING DETACHED FROM TUBING-TUBING CONNECTOR, TUBING CONNECTOR IS CRACKED, SPLIT, DEFORMED, LEAKAGE MAY OCCUR. THE NUMBER OF COMPLAINTS IS 1. THE COMPLAINT NUMBERS ARE COMPLAINT (B)(4). DHR REVIEW: THE LOT 6000331 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) AND MANUFACTURED IN THE M12, ON 15/MAR/2023 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY LOT 3C02840 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) AND ASSEMBLED IN THE QUICKSET LINE, ON 15-MAR-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3C02841 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) AND ASSEMBLED IN THE QUICKSET LINE, ON 15-MAR-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: TUBING GLUING LOT 3C02799 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) AND MANUFACTURED IN THE MACHINE MP08, ON 14-MAR-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3C02800 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) AND MANUFACTURED IN THE MACHINE MP04, ON 14-MAR-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3C02816 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) AND MANUFACTURED IN THE MACHINE MP05, ON 14-MAR-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3C02817 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) AND MANUFACTURED IN THE MACHINE MP08, ON 15-MAR-2023, 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. CAPA DETERMINATION ASSESSMENT - 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 WORK INSTRUCTION (WI) (MONTHLY TRIPS AND ALERTS). THE INVESTIGATION FOR THIS COMPLAINT WAS PREVIOUSLY COMPLETED ON 04-MAR 2024 UNDER CHILD COMPLAINT INVESTIGATION RECORD (B)(4). THE INVESTIGATION HAS BEEN REVISED TO REFLECT THE UPDATED MALFUNCTION CODE AND NEW REPORTABILITY REQUIREMENTS. THE ORIGINAL INVESTIGATION REMAINS VALID AND HAS NOT BEEN MODIFIED. AS PART OF THIS REASSESSMENT, AN UPDATED EQMS SEARCH WAS PERFORMED WHICH IDENTIFIED ONE RELATED COMPLAINTS FOR LOT 6000331. NO NON-CONFORMANCE REPORT, CAPAS, TRENDS, OR SYSTEMIC ISSUES WERE FOUND. AS REQUIRED UNDER THE UPDATED REPORTABILITY CRITERIA, A FULL DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED. ALL IN PROCESS AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS, AND NO DEVIATIONS, REWORK ACTIVITIES, OR MAINTENANCE EVENTS ASSOCIATED WITH THE MALFUNCTION WERE IDENTIFIED. NO VISUAL EVIDENCE WAS AVAILABLE TO SUPPORT CONFIRMATION OF THE REPORTED ISSUE. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THE EXPANDED INVESTIGATION INCLUDING UPDATED EQMS SEARCHES AND THE DHR REVIEW NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WORK INSTRUCTION (WI) (MONTHLY TRIPS AND ALERTS). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE MALFUNCTION REMAINS UNCONFIRMED FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFUSION SET TUBING DETACHED NEAR THE QUICK RELEASE ON (B)(6) 2024. THE INFUSION SITE WAS THE WAIST LEFT SIDE OF BELLY BUTTON. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775129 QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6000331 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown