BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 22836677 · Received August 19, 2025

    Report

    Report Number
    3003442380-2025-12946
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    June 4, 2025
    Report Date
    January 26, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K991759
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNOMEDICAL HEREBY SUBMITS THIS SUPPLEMENTAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN /FDA ACTION PLAN. THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS SUPPLEMENTAL 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. ADDITIONAL INFORMATION - THIS MEDICAL DEVICE REPORT (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 WAS CONDUCTED BASED ON THE EVENT DESCRIPTION AND THE ASSIGNED MALFUNCTION CODE SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL -BLOCKAGE . ADDITIONAL INFORMATION WAS REQUESTED TO SUPPORT THE INVESTIGATION; HOWEVER, A LOT NUMBER INFORMATION WAS NOT PROVIDED. NO DEVICE, DEVICE COMPONENTS, OR OTHER VISUAL OR PHYSICAL EVIDENCE WAS MADE AVAILABLE FOR EVALUATION. CONSEQUENTLY, VISUAL INSPECTION, RETAIN-SAMPLE TESTING, OR THE ASSESSMENT OF POTENTIAL PRODUCT PERFORMANCE ISSUES, COMPONENT INTEGRITY, OR MANUFACTURING DEFECTS COULD NOT BE PERFORMED. IN RESPONSE TO THE COMPLAINT AND DUE TO THE ABSENCE OF A SPECIFIC LOT NUMBER, A HIGH LEVEL INVESTIGATION WAS CONDUCTED FOR THE MINIMED QUICK SET PRODUCT FAMILY AND THE ASSIGNED MALFUNCTION. THE INVESTIGATION INCLUDED AN ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH, ASSESSMENT OF COMPLAINT TRENDS, AND REVIEW OF RELEVANT RISK MANAGEMENT FILES. THE ASSESSMENT OF COMPLAINT DATA FOR THE APPLICABLE PRODUCT FAMILY IDENTIFIED AN ELEVATED TREND FOR THE ASSIGNED MALFUNCTION. THEREFORE, A CORRECTIVE AND PREVENTIVE ACTION CAPA 2537337 WAS INITIATED TO FURTHER ANALYZE THE TREND AND IMPLEMENT CORRECTIVE AND/OR PREVENTIVE ACTIONS AS WARRANTED BY THE FINDINGS. PLEASE REFER TO THE ATTACHED MEMO FOR FULL INVESTIGATION DETAILS: MINIMED QUICK-SET CANNULADOCX ENCLOSURE 1: EQMS SEARCH RESULTS . ENCLOSURE 2: MAINTENANCE RESULTS . ENCLOSURE 3: RAW DATA FOR COMPLAINT TRENDING . CAPA DETERMINATION. BASED ON THE INVESTIGATION, A CORRECTIVE AND PREVENTIVE ACTION CAPA 2537337 WAS INITIATED TO FURTHER ANALYZE THE TREND AND IMPLEMENT CORRECTIVE AND/OR PREVENTIVE ACTIONS AS WARRANTED BY THE FINDINGS. NO ADDITIONAL ACTIONS ARE REQUIRED AT THE INDIVIDUAL COMPLAINT LEVEL AT THIS TIME. THE COMPLAINT RECORD WILL BE CLOSED AND CONTINUE TO BE MONITORED THROUGH ROUTINE TRACKING AND TRENDING PER WORK INSTRUCTION (WI) (MONTHLY TRIPS AND ALERTS). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS INDIVIDUAL COMPLAINT. COMPLAINT INVESTIGATION - CONCLUSION. DUE TO THE ABSENCE OF A LOT NUMBER AND RETURNED PRODUCT, THE INVESTIGATION WAS LIMITED TO A HIGH LEVEL REVIEW OF THE MINIMED QUICK SET PRODUCT FAMILY, INCLUDING AN EQMS SEARCH, COMPLAINT TRENDING, AND REVIEW OF APPLICABLE RISK MANAGEMENT DOCUMENTATION. COMPLAINT TRENDING FOR THE PRODUCT FAMILY INDICATED AN ELEVATED RATE FOR THE REFERENCED MALFUNCTION, PROMPTING INITIATION OF A CAPA TO FURTHER ANALYZE THE TREND AND IMPLEMENT CORRECTIVE AND/OR PREVENTIVE ACTIONS AS WARRANTED BY THE FINDINGS. NO FURTHER ACTION IS REQUIRED AT THE INDIVIDUAL COMPLAINT LEVEL AT THIS TIME. THE RECORD WILL BE CLOSED WITH CONTINUED MONITORING THROUGH ROUTINE TRACKING AND TRENDING PER WORK INSTRUCTION (WI) (MONTHLY TRIPS AND ALERTS). THE RECORD MAY BE REASSESSED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6) PATIENT COUNTRY: BRAZIL. H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS OR REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONCLUDED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    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 BRAZIL. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 AND EVENTUALLY SHIFTED TO INTENSIVE CARE UNIT (ICU) DUE TO KINKED CANNULA LEADING TO HYPERGLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS 250 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS INSULIN. LENGTH OF HOSPITALIZATION WAS FOR 2 DAYS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628240 QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A UNKNOWN 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H