BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 21533467 · Received March 6, 2025

    Report

    Report Number
    3003442380-2025-02905
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    January 27, 2025
    Report Date
    July 10, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244022386
    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) - MDR 3003442380-2025-02905- DEVICE 2 OF 3

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR 2130412 - MDR 3003442380-2025-02905 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. THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6007939 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3.0 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2.0 FOR THE CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WI VERSION 2.0 ON REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6007939 WAS MANUFACTURED ACCORDING TO THE WI VERSION 115 IN THE LINE 3, ON 02/JUL/2024, WITH A TOTAL OF 29,400 UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 08/JUL/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE AND LOT 6007939 AND ANOTHER 2 COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6007939 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: THIS IS A COMPLAINT WHICH IS BEING ADDRESSED AS PART OF A CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN (B)(4): "AUTOSOFT 90, KINKED SOFT CANNULA ISSUES WHICH HAS BEEN OPENED AS A RESULT OF TRENDING ACTIVITIES. THIS COMPLAINT IS A REPORTABLE WITH VALID LOT NUMBER/PRODUCT CODE. CAPA DETERMINATION RESULTS: THIS COMPLAINT FALLS UNDER THE SCOPE OF THE CAPA 1768101: "AUTOSOFT 90, KINKED SOFT CANNULA ISSUES" AND WILL COVER INSET I (AUTOSOFT XC DHF-13.8 & 13.13) AND INSET II (AUTOSOFT 90 DHF-14 AND 14.3) PRODUCTS. ROOT CAUSE OF PROBLEM: THE ROOT CAUSE HAS BEEN IDENTIFIED AS: METHOD, MANPOWER, MEASUREMENT, MACHINE: CORRECTIVE ACTION AS A RESULT OF THE INVESTIGATION: THE ACTION PLAN AND DEADLINES IS AS FOLLOWED: THE FOLLOWING ACTIONS WERE ALREADY IMPLEMENTED IN THE NC (B)(4) 1. INCLUDE THE DEFECT IN DOCUMENT (B)(4) (WORK INSTRUCTION INSET LINE) 2. IMPROVE GUARDS OF THE CONVEYORS 3. UPDATE TRAYS FOR THE STOCK OF CANNULAS 4. UPDATE DOCUMENT (B)(4) (QUALITY SPECIFICATION FOR CATHETER FIXTURE FOR SKEWED CATHETERS) FOR INCLUDE THE HANDLING OF THE CATHETER DURING THE PROCESS. 5. UPDATE THE DOCUMENT (B)(4) (WORK INSTRUCTION INSET LINE) TO INCLUDE THE PREVENTIVE ACTIONS IMPLEMENTED IN THE PROCESS (TRAYS) A REMAINING ACTION (TO ADDRESS DESIGN ROOT CAUSE) AND DEADLINES IS AS FOLLOWED: ADD CYLINDERS TO THE LID TO MAINTAIN IN POSITION THE NEEDLE AND CANNULA DURING TRANSPORTATION AND PRIOR USE (DATABASE(B)(4)- (B)(6) 2025).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFUSION SET CANNULA WAS BENT WITHIN AFTER THREE HOURS OF INSERTION AT THIGH AND ABDOMEN ON (B)(6) 2025, WHICH RESULTED IN ELEVATED BLOOD GLUCOSE (585 MG/DL), THEREFORE PATIENT HAD RECEIVED CORRECTION INJECTION VIA MULTIPLE DAILY INJECTIONS (MDI). IT WAS ALSO REPORTED THAT THE PATIENT WENT TO EMERGENCY ROOM (ER) AND SUBSEQUENTLY GOT HOSPITALIZED ON (B)(6) 2025 AND ADMITTED IN INTENSIVE CARE UNIT (ICU) RECEIVED IV (INTRAVENOUS) AND FLUIDS OF SALINE AND INSULIN. THE PATIENT HAD HIGH KETONES WHICH WERE LIFE THREATENING. THE INFUSION SET WAS IN USE FOR THREE DAYS. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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 WAS 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
    811912 AUTOSOFT XC UNO INSET I 12/6 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1006922 6007939 05705244022386

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female Hospitalization| R| L