BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 20732937 · Received November 20, 2024

    Report

    Report Number
    3003442380-2024-32492
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    September 28, 2024
    Report Date
    August 8, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244025202
    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

    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 6003662 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THE REFERENCE SAMPLES FOR THE LOT 6003662 HAVE ALREADY BEEN PREVIOUSLY TESTED FOR VISUAL INSPECTION AND TESTED FOR FLOW IN THE DATABASE COMPLAINT (B)(4) ON 09/JAN/2024. ALL TEST RESULTS WERE FOUND WITHIN SPECIFICATIONS AS PER THE TEST REPORT DATABASE COMPLAINT (B)(4) TEST REPORT. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD 6003662 WAS VERIFIED AND FOUND IT WITHIN SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003662 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 108 MANUFACTURED IN THE LINE INSET 6, ON 06/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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 07/AUG/2025 AGAINST MALFUNCTION WITH SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE AND LOT 6003662 AND NINETEEN OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6003662 AND MALFUNCTION CODE. CONCLUSION AND SUMMARY: 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. CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION RESULTS: THIS COMPLAINT FALLS UNDER THE SCOPE OF THE CORRECTIVE AND PREVENTIVE ACTION (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 WENT TO EMERGENCY ROOM DUE TO INFUSION SET'S BENT CANNULA EVENT ON 28-SEP-2024. PATIENT'S BLOOD GLUCOSE LEVEL AT THE TIME OF ISSUE WAS 400 MG/DL. PATIENT EXHIBITED MINIMAL LEVEL OF KETONES. PATIENT WAS TREATED VIA SALINE. PATIENT WAS HOSPITALIZED FOR FEW 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
    1995701 INSET UNO INSET I 60/6 GREY BETA 10PK INT FPA UNOMEDICAL A/S FG000016-01 6003662 05705244025202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other