BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT 90

    MDR report key: 21054341 · Received January 2, 2025

    Report

    Report Number
    3003442380-2024-35700
    Event Type
    Injury
    Date Received
    January 2, 2025
    Date of Event
    November 28, 2024
    Report Date
    August 18, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 FOR THE MALFUNCTION CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE. THE BATCH 6000762 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. PHYSICAL SAMPLES WERE FORMALLY REQUESTED; HOWEVER, THEY WERE NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. HOWEVER, THE REFERENCE SAMPLES FOR BATCH 6000762 WERE PREVIOUSLY TESTED IN COMPLAINT (B)(4) ON 22/NOV/2023. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING LOT 6000762 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 103 IN THE LINE 1, ON 23/APR/2023, WITH A TOTAL OF (B)(4) 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/AUG/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE AND LOT 6000762 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6000762 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) 1768101: "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 1515780 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 (TW#(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 FACED AN INFUSION SET CANNULA KINKED EVENT ON (B)(6) 2024 LEADING TO HOSPITALIZATION. THE PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT (ICU) DUE TO HYPERGLYCEMIA ON (B)(6) 2024. THE EVENT OCCURED THREE OR MORE HOURS AFTER INSERTION. THE SITE OF INSERTION WAS AT ABDOMEN. THE BLOOD GLUCOSE LEVEL WAS 453 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. THE LEVEL OF KETONES WAS HIGH AND LIFE THREATENING. THE INFUSION SET WAS IN USE FOR TEN TO TWELVE HOURS. 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
    1185321 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1002817 6000762 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Hospitalization| L| R