BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 23885909 · Received December 23, 2025

    Report

    Report Number
    3003442380-2025-17557
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    November 24, 2025
    Report Date
    March 27, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K991759
    Product Problem
    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 EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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. THIS INVESTIGATION HAS BEEN UPDATED BECAUSE THE MALFUNCTION CODE CHANGED FROM CANNULA HOUSING/BASE PIECE DETACHED OR PARTLY DETACHED FROM ADHESIVE PATCH DURING USE (WELDING), TO CANNULA HOUSING/BASE PIECE DETACHED OR PARTLY DETACHED FROM ADHESIVE PATCH DURING INSERTION, WHICH REQUIRES ADDITIONAL ACTIVITIES NOT INCLUDED IN THE ORIGINAL INVESTIGATION DATED 30-DEC-2025. ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 27-MAR-2026 AGAINST "LOT NUMBER 6013283 AND SIMILAR MALFUNCTION CODES: CANNULA HOUSING/BASE PIECE DETACHED OR PARTLY DETACHED FROM ADHESIVE PATCH DURING INSERTION. CANNULA HOUSING/BASE PIECE DETACHED OR PARTLY DETACHED FROM ADHESIVE PATCH DURING INSERTION (WELDING). THE REVIEW CONFIRMED THAT LOT 6013283 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NONCONFORMING REPORTS (NCR)S OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 27-MAR-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6013283 AND SIMILAR MALFUNCTION CODES CANNULA HOUSING/BASE PIECE DETACHED OR PARTLY DETACHED FROM ADHESIVE PATCH DURING INSERTION. CANNULA HOUSING/BASE PIECE DETACHED OR PARTLY DETACHED FROM ADHESIVE PATCH DURING INSERTION (WELDING). THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBERS ARE (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013283 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC 12, ON 15-MAY-2025, WITH A TOTAL OF (B)(4). THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 5E01602 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE 04 -08, ON 12-MAY-2025, WITH A TOTAL OF (B)(4). THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 5E00298 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE 08 -04, ON 11-MAY-2025, WITH A TOTAL OF (B)(4). THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 5E01602 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE 08 -04, ON 12-MAY-2025, WITH A TOTAL OF (B)(4). THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 5E01606 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE 08 -04, ON 15-MAY-2025, WITH A TOTAL OF (B)(4). 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. 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). FINAL CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: THE INVESTIGATION FOR THIS COMPLAINT WAS PREVIOUSLY COMPLETED ON 30/DEC/2025, UNDER CHILD COMPLAINT INVESTIGATION RECORD (B)(4). THE INVESTIGATION HAS BEEN REVISED TO REFLECT THE UPDATED MALFUNCTION CODE. 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 COMPLAINT FOR LOT 6013283. NO NCRS, 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 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 FACED ADHESIVE PATCH TORE OFF FROM THE PLASTIC PART EVENT ON (B)(6) 2025. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO ADDITIONAL 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
    80568 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6013283 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown