BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 22696824 · Received August 4, 2025

    Report

    Report Number
    3003442380-2025-12239
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 14, 2025
    Report Date
    September 25, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018181
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2025-12239. 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 21 OF PROCEDURE 3709030, 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 6010457, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010457 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 AND MANUFACTURED IN THE LINE 7 ON 29-NOV-2024, 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: 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. 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 UNITED KINGDOM. IT WAS REPORTED THAT THE PATIENT FACED FIVE INFUSION SETS LEAKAGE EVENTS ON (B)(6) 2025. THE LEAKAGE WAS IN THE CANNULA. THE INSERTION SITE WAS THA ABDOMEN. PATIENT ALSO EXPERIENCED BLEEDING 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
    202788 INSET II UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002819 6010457 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown