BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNO INSET II 60/6 GREY TCAP 10PK INT

    MDR report key: 19686728 · Received July 7, 2024

    Report

    Report Number
    3003442380-2024-12633
    Event Type
    Malfunction
    Date Received
    July 7, 2024
    Date of Event
    March 27, 2024
    Report Date
    November 1, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018242
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MDR (B)(4). MDR 3003442380-2024-12633. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER UNDER D4, AND MANUFACTURING NUMBER UNDER H4. 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 (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 6003320, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003320 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 107 AND MANUFACTURED IN THE LINE 6 ON 23-SEP-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBE OF THE LOT 3J01573 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 55 AND MANUFACTURED IN THE MACHINE SC02, ON 22-SEP-2023, 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: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT 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 MDR (B)(4). DEVICE 2 OF 10.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT 10 INFUSION SETS LEAKED AT SITE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394425 UNO INSET II 60/6 GREY TCAP 10PK INT UNO INSET II 60/6 PINK TCAP 10PK INT FPA UNOMEDICAL A/S 1002821 6003320 05705244018242

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female