BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23049210 · Received September 15, 2025

    Report

    Report Number
    3003442380-2025-13681
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    July 27, 2025
    Report Date
    October 6, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244025288
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 - PER REVISION (B)(4) OF PROCEDURE (B)(4), A CHILD INVESTIGATION IS NOT REQUIRED TO DOCUMENT THE DHR REVIEW FOR A TYPE 2 REPORTABLE COMPLAINT. HOWEVER, THE CHILD WAS CREATED TO ALLOW THE PARENT RECORD TO ADVANCE TO REVIEW AND SUMMARY. SINCE IT WAS CREATED, THE DHR REVIEW WAS DOCUMENTED WITHIN THE CHILD. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6011329, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011329 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 100 AND PACKAGING IN THE MULTIVAC M14 ON 02-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: WELDING OF THE LOT 5A04033 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 34 AND MANUFACTURED IN THE MACHINE LS24-LS25, ON 28-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING CONNECTOR OF THE LOT 5A03998 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 37 AND MANUFACTURED IN THE LINE L3, ON 28-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING CONNECTOR OF THE LOT 5A03999 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 37 AND MANUFACTURED IN THE LINE L3, ON 28-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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET BENT NEEDLE EVENT ON (B)(6) 2025. INFUSION SET WAS USED FOR 12 HOURS. BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF THE EVENT. 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
    2047977 CONTACT DETACH UNO CONTACT DETACH G29 60/6 BETA FPA UNOMEDICAL DEVICES S.A. DE C.V. FG000016-03 6011329 05705244025288

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown