BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNO EWIS BLUE 80/9 HCAP 3-PK INT

    MDR report key: 19786223 · Received July 20, 2024

    Report

    Report Number
    8021545-2024-02317
    Event Type
    Malfunction
    Date Received
    July 20, 2024
    Date of Event
    May 20, 2024
    Report Date
    September 26, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016927
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT (B)(4) HAS BEEN EVALUATED. THE LOT 6003885 IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTIONS (WI) GUIDELINE FOR TEST OF REFERENCE. SAMPLES VERSION 11 FOR THE CODE LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED). COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAS BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WITH VERSION 15 QUALITY SPECIFICATION - INSET GUARD RAMP-UP AND INSET GUARD EWIS. TEST ON RETURNED REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO VERSION 10 FLOW TESTS IN CUSTOMER COMPLAINTS. DOC TEST ON REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO VERSION 25 INSTRUCTIONS FOR USING LEAK DETECTION EQUIPMENT IN THE INSPECTION AREA. DOC TEST ON REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. BATCH REVIEW THE LOT 6003885 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 14 ON THE PACKING PROCESS IN THE MACHINE SL01 / LINE MV11, ON 01/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: NO REPORTED HARM, NO DEFECT ON TEST, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    (B)(4) - MDR 3003442380-2024-12630- DEVICE 1 OF 2

    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 CANADA. IT WAS REPORTED THAT THE INFUSION SET LEAKS AT SITE AFTER 3 DAYS OF USAGE.. NO FURTHER INFORMATION AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645671 UNO EWIS BLUE 80/9 HCAP 3-PK INT MEDTRONIC EXTENDED FPA UNOMEDICAL A/S MMT-442AH 6003885 05705244016927

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown