BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23567620 · Received November 17, 2025

    Report

    Report Number
    3003442380-2025-16545
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 14, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018426
    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. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6014008, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6014008 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND PACKAGING IN THE MULTIVAC 14, ON 28/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING THE LOT 5E03930 WAS MANUFACTURED ACCORDING TO THE WI VERSION 68 AND MANUFACTURED IN THE SC05, AND SC06 ON 15-JUN-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. NOTE: EXTENDED BY: NEEDLE OUT OF SPECIFICATION, IT DOES NOT AFFECT THE MALFUNCTION CODE THE SUB-ASSEMBLY, WELDING THE LOT 5F04174 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 WELDING IN THE MACHINE LS24, AND LS25, ON 27/JUN/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5F04163 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 WELDING IN THE MACHINE LS06, AND LS07, ON 26/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5F04177 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 WELDING IN THE MACHINE LS06, AND LS07, ON 28/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5F04175 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 WELDING IN THE MACHINE LS24, AND LS25, ON 28/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR THE LOT 5F03889 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 26/JUN/2025, WITH A TOTAL OF (B)(4) UNITS, THE LOT 5F03941 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 27/JUN/2025, WITH A TOTAL OF (B)(4) UNITS, THE LOT 5F03942 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 28/JUN/2025, WITH A TOTAL OF (B)(4) UNITS, THE LOT 5F03943 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 28/JUN/2025, WITH A TOTAL OF (B)(4) UNITS, THE LOT 5F03944 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 29/JUN/2025, WITH A TOTAL OF (B)(4) UNITS, THE LOT 5F03945 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 29/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. 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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4) EVENT OCCURED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED OCCLUSION EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. 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
    50231 CONTACT DETACH UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002833 6014008 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female