BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23241787 · Received October 8, 2025

    Report

    Report Number
    3003442380-2025-14744
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    April 9, 2025
    Report Date
    February 10, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01- (B)(4) - MDR 3003442380-2025-14744. 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: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6011130 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011130 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 98 AND PACKAGING IN THE MULTIVAC 14, ON 18-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING: THE LOT 4M03247 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 WELDING IN THE MACHINE LS25 & LS24, ON 16-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4M03243 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 WELDING IN THE MACHINE LS06 & LS07, ON 06-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR: THE LOT 4M03223 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 07-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4M03226 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 17-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4M03220 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 22-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4M03222 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 06-JAN-2025, 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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL (B)(4) - DEVICE 5 OF 5.

    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 FRANCE. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2025. THE LEAKAGE WAS BETWEEN THE TUBE AND THE CARTRIDGE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2610895 CONTACT DETACH UNO CONTACT DETACH G29 80/8TCAP 10PK INT FPA UNOMEDICAL UM-D 1002836 6011130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown