BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE-T PARADIGM

    MDR report key: 19491550 · Received June 7, 2024

    Report

    Report Number
    3003442380-2024-07141
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 6, 2024
    Report Date
    March 27, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244019348
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT COUNTRY: CHINA. PATIENT CITY: BEIJING.

    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 PR (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING). THE BATCH 6000931 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATION: 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 FOR THE LOT 6000931 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE PR 1831147 ON 14/FEB/2024. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT DATABASE PR (B)(4) COMPLAINT TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE PACKAGING LOT 6000931 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 90 MANUFACTURED IN THE LINE MULTIVAC 14, ON 01/APR/2023, WITH A TOTAL OF (B)(4) UNITS. THE GLUING TUBE LOT 3C06775 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 MANUFACTURED IN THE MACHINE SC06, ON 30/MAR/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 26/MAR/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING). THE BATCH 6000931 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE AND LOT 6000931 AND NO OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM REPORTED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA IT WAS REPORTED THAT PATIENT FACED AN INFUSION SET WAS LEAKING AT QUICK RELEASE EVENT ON 06-MAY-2024. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031156 SURE-T PARADIGM UNO CONTACT DETACH G29 80/6 SC1 MIMX FPA UNOMEDICAL A/S MMT-866A 6000931 05705244019348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown