BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET W. LUER-LOCK, 10PK, US, 6MM/23", GREY, INF SET

    MDR report key: 20639061 · Received November 8, 2024

    Report

    Report Number
    3003442380-2024-30862
    Event Type
    Injury
    Date Received
    November 8, 2024
    Date of Event
    June 10, 2024
    Report Date
    September 11, 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

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED MANUFACTURING DATE UNDER H4. 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 REFERENCE SAMPLES FOR THE LOT 6005835 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(6) ON 08/AUG/2025. 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. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT DATABASE 1950992 COMPLAINT TEST REPORT DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6005835 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 111, MANUFACTURED IN THE LINE 6, ON 25/FEB/2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 12/AUG/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE AND LOT 6005835 AND OTHER 1 COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 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 (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 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 NON-CONFORMANCE (NC) 1. INCLUDE THE DEFECT IN DOCUMENT 4805074 (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)- 30/SEP/2025).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT, THE PATIENT WAS "HOSPITALIZED" ON (B)(6) 2024 DUE TO BENT CANNULA ISSUE AND HAD KETONES AND VOMITING. 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
    1944597 INSET W. LUER-LOCK, 10PK, US, 6MM/23", GREY, INF SET UNO INSET I 60/6 GREY BETA 10PK INT FPA UNOMEDICAL A/S FG000016-01 6005835 05705244025202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization