BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23567325 · Received November 17, 2025

    Report

    Report Number
    3003442380-2025-16480
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    August 21, 2025
    Report Date
    December 10, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244005693
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER, EXPIRATION DATE UNDER D4 AND 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. COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM SEARCH: A QUERY WAS RUN IN THE EQMS ON 09-DEC-2025 AGAINST "LOT NUMBER 6011604 AND SIMILAR MALFUNCTION CODE(S): TUBING IS DAMAGED (E.G. KINKED, DEFORMED, TWISTED, COLLAPSED OR PINCHED), OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS REDUCED FLOW, OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS BLOCKAGE. THE REVIEW CONFIRMED THAT LOT 6011604 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 09-DEC-2025 AGAINST "LOT NUMBER" CRITERIA EQUAL 6011604 AND SIMILAR MALFUNCTION CODES: TUBING IS DAMAGED (E.G. KINKED, DEFORMED, TWISTED, COLLAPSED OR PINCHED), OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS REDUCED FLOW, OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS BLOCKAGE. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBER IS COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011604 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 100 AND MANUFACTURED IN THE MULTIVAC 14 ON 15-FEB-2025 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 5B02438 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66 AND MANUFACTURED IN THE MACHINE SC02, SC06, ON 14-FEB-2025, 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. CORRECTIVE AND PREVENTIVE ACTION (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).

    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 THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING PUNCTURED EVENT ON (B)(6) 2025. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490777 CONTACT DETACH UNO CONTACT DETACH G29 60/6 MIMX FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-863 6011604 05705244005693

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown