BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE-T

    MDR report key: 20553960 · Received October 29, 2024

    Report

    Report Number
    3003442380-2024-30112
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    September 30, 2024
    Report Date
    April 21, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244019348
    PMA / PMN Number
    K041545
    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 REFERENCE SAMPLES FOR THE LOT 6003865 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE CASE 1965147. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAS BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WITH WORK INSTRUCTION (WI) VERSION 2 ON REFERENCE SAMPLES, (B)(4)SAMPLES OUT (B)(4) SAMPLES PASSED THE TEST. FUNCTIONAL TEST ACCORDING TO WI VERSION 1 ON REFERENCE SAMPLES, (B)(4)SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003865 WAS MANUFACTURED ACCORDING TO THE WI VERSION 94 MANUFACTURED IN THE LINE/MACHINE M10, ON 25/OCT/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, NO MAINTENANCE EVENTS WERE RECORDED. DHR REVIEW (GLUING TUBING): THE LOT 3K02553 WAS MANUFACTURED ACCORDING TO THE WI VERSION 57 MANUFACTURED IN THE LINE/MACHINE SC05-SC06, ON 23/OCT/2023, WITH A TOTAL OF 30,900 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, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 27/FEB/2025 AGAINST MALFUNCTION TUBING DETACHED FROM HUB) AND LOT 6003865 AND 1 OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6003865 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN HONG KONG. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET TUBING DETACHED EVENT ON 30-SEP-2024. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928642 SURE-T UNO CONTACT DETACH G29 80/6 SC1 MIMX FPA UNOMEDICAL A/S MMT-866A 6003865 05705244019348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown