BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 23702169 · Received December 3, 2025

    Report

    Report Number
    3003442380-2025-16837
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    October 31, 2025
    Report Date
    June 2, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2025-16837. 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 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 STEEL CANNULA IS FOUND BENT UPON REMOVAL FROM INFUSION SITE - BLOCKAGE ADDITIONAL INFORMATION WAS REQUESTED TO SUPPORT THE INVESTIGATION; HOWEVER, A LOT NUMBER OR ANY PRODUCT SPECIFIC 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 OR PART NUMBER, A HIGH-LEVEL INVESTIGATION WAS CONDUCTED FOR THE ASSIGNED MALFUNCTION IN INFUSION SET PRODUCTS DISTRIBUTED TO THE CUSTOMER. THIS INCLUDED BUT IT WAS NOT LIMITED TO AUTOSOFT XC, AUTOSOFT XC (5 INCH), AUTOSOFT 90, AUTOSOFT 30, AUTOSOFT 30 T-LOCK, AND VARISOFT PRODUCT FAMILIES. THE INVESTIGATION INCLUDED AN ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH, ASSESSMENT OF COMPLAINT TRENDS, AND REVIEW OF APPLICABLE RISK MANAGEMENT DOCUMENTATION. NO SYSTEMIC ISSUES WERE IDENTIFIED DURING THIS HIGH-LEVEL REVIEW. PLEASE REFER TO THE ATTACHED MEMOS FOR FULL DETAILS. AUTOSOFT XC CANNULA AUTOSOFT 30 TLOCK LOSS OF PHYSICAL INTEGRITY CANNULA AUTOSOFT 90 CANNULA AUTOSOFT XC (5 INCHES) CANNULA INVESTIGATION CLOSURE REPORT AUTOSOFT 30 LOSS PHYSICAL INTEGRITY (CANNULA) VARISOFT 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, PART NUMBER, AND RETURNED PRODUCT, THE INVESTIGATION WAS LIMITED TO A HIGH-LEVEL REVIEW OF THE ASSIGNED MALFUNCTION IN INFUSION SET PRODUCTS DISTRIBUTED TO THE CUSTOMER. THIS INCLUDED BUT IT WAS NOT LIMITED TO AUTOSOFT XC, AUTOSOFT XC (5 ]INCH), AUTOSOFT 90, AUTOSOFT 30, AUTOSOFT 30 T-LOCK, AND VARISOFT PRODUCT FAMILIES. THE REVIEW INCLUDED 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.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL (B)(4) - DEVICE 2 OF 4. SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. 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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET BENT CANNULA EVENT ON (B)(6) 2025 AND (B)(6) 2025. THE PATIENT FACED THIS ISSUE WITH 4 INFUSION SETS. THE INFUSION SET WAS IN USE FOR ONE DAY. THE SYMPTOMS WERE NOTICED WITHING 3 HOURS OF INSERTION. THE SITE OF INSERTION WAS ABDOMEN AND THIGH. THERE WAS HIGH BLOOD GLUCOSE LEVEL FOR WHICH THE PATIENT VISITED EMERGENCY ROOM ON (B)(6) 2025. THE PATIENT WAS IN EMERGENCY ROOM FOR 5 HOURS. THE PATIENT GOT TREATED WITH INTRAVENOUS (IV) FLUIDS AND SALINE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2853974 UNKNOWN UNKNOWN FPA UNOMEDICAL DEVICES S.A. DE C.V. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female Required Intervention