BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 22989874 · Received September 8, 2025

    Report

    Report Number
    3003442380-2025-13457
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 11, 2025
    Report Date
    September 4, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    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 6010692, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 03-SEP-2025 AGAINST "FINAL REPORTING DECISION EQUAL "REPORTABLE", "LOT NUMBER" CRITERIA EQUAL "6010692". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010692 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 12 ON 13-DEC-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT A NON-CONFORMANCE (NC) WAS OPENED DURING THE STERILIZATION PROCESS AND FURTHER PRODUCT DISPOSITION WERE REQUIRED. THE SUB-ASSEMBLY GLUING OF TUBING OF THE LOT 4M01589 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 65 AND MANUFACTURED IN THE MACHINE SC02, ON 09-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. TEST RESULTS: IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE(S) FROM THE LOT HAVE BEEN REQUESTED. NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, ONE NON-CONFORMANCE (NC) RAISED DURING PRODUCTION UNRELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION, 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

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER AND PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER UNDER D4. 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 6009397, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6009397 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 117 AND MANUFACTURED IN THE LINE INSET 6 ON 27/SEP/2024, WITH A TOTAL OF (B)(4) UNITS. GLUE TUBING DHR REVIEW: THE LOT 4J03190 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 MANUFACTURED IN THE MACHINE SC02, ON 25/SEP/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4J01462 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 MANUFACTURED IN THE MACHINE SC09, ON 19/SEP/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4J04339 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 MANUFACTURED IN THE MACHINE SC02, ON 27/SEP/2024, WITH A TOTAL OF (B)(4) UNITS. REIEW 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 GERMANY. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET LEAKAGE EVENT ON (B)(6) 2025 AT CATHETERS. 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
    2068130 INSET II UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002817 6010692 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown