BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 21802970 · Received April 9, 2025

    Report

    Report Number
    3003442380-2025-05758
    Event Type
    Injury
    Date Received
    April 9, 2025
    Date of Event
    February 8, 2025
    Report Date
    January 23, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4). DEVICE 1 OF 3. 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 WOULD FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR 2162878. UNOMEDICAL HEREBY SUBMITS THIS SUPPLEMENTAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CAPA/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: INVESTIGATION RESULTS UNDER INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS. 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 AUTOSOFT XC PRODUCT FAMILY AND THE ASSIGNED MALFUNCTION. THE INVESTIGATION ENCOMPASSED AN ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH, ASSESSMENT OF COMPLAINT TRENDS, AND THE REVIEW OF RISK MANAGEMENT FILES. NO SYSTEMIC ISSUES WERE IDENTIFIED. PLEASE REFER TO THE ATTACHED MEMO FOR FULL DETAILS: AUTOSOFT XC_CANNULA. ENCLOSURE 1: EQMS SEARCH RESULTS. ENCLOSURE 2: MAINTENANCE RESULTS. ENCLOSURE 3: RAW DATA FOR COMPLAINT TRENDING. CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION. BASED ON THE INVESTIGATION, NO FURTHER ACTION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WORK INSTRUCTION (WI) (MONTHLY TRIPS AND ALERTS). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS 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 AUTOSOFT XC PRODUCT FAMILY, INCLUDING AN EQMS SEARCH, COMPLAINT TRENDING, AND REVIEW OF APPLICABLE RISK MANAGEMENT DOCUMENTATION. NO EVIDENCE OF A SYSTEMIC ISSUE WAS IDENTIFIED. NO FURTHER ACTION IS REQUIRED AT THIS TIME, AND THE RECORD WILL BE CLOSED WITH CONTINUED MONITORING THROUGH ROUTINE TRACKING AND TRENDING. THE RECORD MAY BE REASSESSED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 AND EVENTUALLY SHIFTED TO INTENSIVE CARE UNIT (ICU) DUE TO BENT CANNULA. THE BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. NO FURTHER 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
    417001 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001681 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention| H