BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I PORT ADVANCE

    MDR report key: 19835185 · Received July 26, 2024

    Report

    Report Number
    3003442380-2024-16620
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    June 25, 2024
    Report Date
    December 16, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244009394
    PMA / PMN Number
    K120337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: (B)(6).

    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. COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH. A QUERY WAS RUN IN THE EQMS ON 16-DEC-2025 AGAINST "LOT NUMBER 6003943 AND SIMILAR MALFUNCTION CODES: DAMAGED SOFT CANNULA. (E.G., PENETRATED BY INTRODUCER NEEDLE), FOR NEW CODE CREATION. THE REVIEW CONFIRMED THAT LOT 6003943 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 16-DEC-2025 AGAINST "LOT NUMBER" CRITERIA EQUAL 6003943 AND SIMILAR MALFUNCTION CODES: DAMAGED SOFT CANNULA. (E.G., PENETRATED BY INTRODUCER NEEDLE), FOR NEW CODE CREATION. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003943 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 26 AND MANUFACTURED IN THE LINE IPORT ON 19-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES. ALL REQUIRED IN-PROCESS AND FINAL TESTS WERE COMPLETED AND MET SPECIFIED REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED THAT RELATE TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; NO ISSUES NOTED. VISUAL EVIDENCE REVIEW: NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EQMS QUERIES, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD REVIEW, VISUAL EVIDENCE ASSESSMENT, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6003943 AND RELATED MALFUNCTION CODES FOR CANNULA WAS LEFT AT SITE. ONE COMPLAINT WAS IDENTIFIED FOR THIS LOT, BUT NO TREND OR SYSTEMIC ISSUE WAS DETECTED. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED, AND NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT OF BROKEN CANNULA. PATIENT WAS A MINOR AND PATIENT'S MOTHER REPORTED THAT IPORT CANNULA SEEMS TO BE 1MM SHORTER WHEN IT WAS REMOVED FROM THE SITE OF INSERTION AFTER BEING USED FOR THREE DAYS. PATIENT'S MOTHER WAS WORRIED THAT A PIECE OF THE CANNULA WAS LEFT AT SITE OF INSERTION WHICH WAS LEG. PATIENT'S MOTHER COMPARED THE SIZES OF THE CANNULA IN QUESTION WITHA RULER VS A NEW CANNULA AND CONFIRMED SIZE DIFFERENCES. CANNULA IN QUESTION WAS 5 MM VS NEW CANNULA WAS 6 MM. THE SITE HOWEVER LOOKED NORMAL AND THE TIP OF THE CANNULA IT DOESN'T SEEM RIPPED. PATIENT'S MOTHER WAS RECOMMENDED TO COMPARE AND MEASURE THE CANNULA ON PATIENT'S NEXT CHANGE AFTER USING IT. 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
    504178 I PORT ADVANCE I-PORT ADVANCE 6 MM FPA UNOMEDICAL A/S MMT-100 6003943 05705244009394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown