BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE-T

    MDR report key: 20082661 · Received August 28, 2024

    Report

    Report Number
    3003442380-2024-22625
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    July 22, 2024
    Report Date
    April 18, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244019317
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6).

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE 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 INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6002554 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 1 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 1 FOR THE CODE TUBING DETACHED FROM HUB. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING WI VERSION 1 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL STATIC PULL OF THE TUBING-TUBING HUB TEST 1 FLOW ACCORDING TO WI VERSION 1 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. SEE ATTACHMENT DATABASE PR 1952031 COMPLAINT TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE 6002554 WAS MANUFACTURED ACCORDING TO THE WI VERSION 94 PACKAGED IN THE MV10, ON 07/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING: THE LOT 3H01439 WAS GLUED ACCORDING TO THE WI VERSION 55, MACHINE SC05, ON 20/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H00666 WAS GLUED ACCORDING TO THE WI VERSION 55, MACHINE SC05, ON 13/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H00665 WAS GLUED ACCORDING TO THE WI VERSION 55, MACHINE SPOT 06, ON 13/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3G0489 2WAS GLUED ACCORDING TO THE WI VERSION 55, MACHINE SC05, ON 06/AUG/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, NOR MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 10/FEB/2025 AGAINST MALFUNCTION CODE TUBING DETACHED FROM HUB AND LOT 6002554 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6002554 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: HARM REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE PMS PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA. ON (B)(6) 2024, PATIENT REPORTED THAT THE INFUSION SET TUBING GOT DETACHED AND PUMP REMAINED CONNECTED TO THE BODY.DETACHMENT. 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
    1464702 SURE-T UNO CONTACT DETACH G29 60/6 SC1 MIMX FPA UNOMEDICAL A/S MMT-864A 6002554 05705244019317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown