BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 21639491 · Received March 19, 2025

    Report

    Report Number
    3003442380-2025-04063
    Event Type
    Injury
    Date Received
    March 19, 2025
    Date of Event
    December 1, 2024
    Report Date
    January 26, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, DA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - DEVICE 1 OF 2. H11: 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.

    Additional Manufacturer Narrative · 0

    MDR (B)(4). 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 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 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 90 CANNULA, AUTOSOFT XC CANNULA, AUTOSOFT XC (5 INCHES) CANNULA, INVESTIGATION CLOSURE REPORT AUTOSOFT 30 LOSS PHYSICAL INTEGRITY (CANNULA), AUTOSOFT 30 TLOCK LOSS OF 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 RELEVANT SOFT CANNULA 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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT EXPERIENCED TWO EVENTS OF INFUSION SET KINKED CANNULA ON (B)(6) 2024 AND (B)(6) 2025. THE INSERTION SITES WAS ABDOMEN AND BUTTOCKS. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT TRIED TO TREAT WITH CORRECTION BOLUS VIA PUMP. HOWEVER, FOR BOTH THE EVENTS, PATIENT WAS HOSPITALIZED AND EVENTUALLY SHIFTED TO INTENSIVE CARE UNIT (ICU) DUE TO KINKED CANNULA WHICH RESULTED INTO HYPERGLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS 800-899 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. THE TRACE KETONES WERE FOUND TO BE HIGH. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. 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
    9205 UNKNOWN UNKNOWN FPA UNOMEDICAL UM-D UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Required Intervention