BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20520505 · Received October 24, 2024

    Report

    Report Number
    3003442380-2024-29076
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    August 1, 2024
    Report Date
    December 4, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026032
    PMA / PMN Number
    K032854
    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: D9: DEVICE AVAILABLE FOR EVALUATION HAS BEEN SELECTED AS YES & DATE RETURNED TO MFG WAS ADDED AS WELL. 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 6002757 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION GUIDELINE FOR TEST OF REFERENCE SAMPLES BUID-UMD VERSION 11 FOR THE CODE " SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE." COMPLAINT INVESTIGATIONS. 1 USED CANNULA PART WAS PROVIDED AND THERE IS VISIBLE THE SOFT CANNULA WAS KINKED AT THE TIP. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WORK INSTRUCTION VERSION 43. 1 USED SET FAILED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WORK INSTRUCTION VERSION 9. 1 USED SET PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6002757 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION VERSION 106 MANUFACTURED IN THE LINE INSET 3, ON 16/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. A QUERY WAS RUN IN TRACKWISE AGAINST MALFUNCTION CODE "SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE" AND LOT NUMBER 6002757 AND OTHER ONE COMPLAINT HAS BEEN REGISTERED IN TRACKWISE SINCE THE LAST 12 MONTHS. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: 1 USED CANNULA PART WAS FOUND WITH THE SOFT CANNULA KINKED AT THE TIP, FAILURE FOUND IS NOT RELATED TO MANUFACTURING PROCESS, NO HARM REPORTED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, OTHER ONE COMPLAINT HAS BEEN REGISTERED IN TRACKWISE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA KINKED EVENT ON (B)(6) 2024. THE PATIENT NOTICED THE SYMPTOMS WITHIN 3 HOURS OF INSERTION. INSERTION SITE WAS ABDOMEN. 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
    2571314 AUTOSOFT XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 6000548 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male