BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED INFUSION SET

    MDR report key: 19736703 · Received July 13, 2024

    Report

    Report Number
    8021545-2024-02001
    Event Type
    Malfunction
    Date Received
    July 13, 2024
    Date of Event
    April 11, 2024
    Report Date
    December 17, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022683
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 02 - (B)(4). 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: CAPA-2010953 "TREND OBSERVED: INCREASE IN COMPLAINTS RELATED TO ADHESIVE ON EWIS" HAS BEEN OPENED ON 18-SEP-2024 TO ADDRESS ALL ADHESIVE ISSUES RELATED TO EWIS PRODUCT FAMILY AS NO SPECIFICATIONS EXIST FOR THE ADHESIVE USED ON THIS PRODUCT (DESIGN RELATED CAPA).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4). ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. CAPA-2010953 "TREND OBSERVED: INCREASE IN COMPLAINTS RELATED TO ADHESIVE ON EWIS" HAS BEEN OPENED ON 18-SEP-2024 TO ADDRESS ALL ADHESIVE ISSUES RELATED TO EWIS PRODUCT FAMILY AS NO SPECIFICATIONS EXIST FOR THE ADHESIVE USED ON THIS PRODUCT (DESIGN RELATED CAPA).

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1911072 - MDR 8021545-2024-02001- DEVICE 2 OF 2. E1: (B)(6).

    Description of Event or Problem · 0

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

    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 PATIENT FACED ADHESIVE ISSUES WITH TWO INFUSION SETS ON (B)(6) 2024. PATIENT REPORTED THAT TAPE WAS NOT STICKING AND LOST 2 INFUSION SETS WHILE TAKING A SHOWER. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862332 MEDTRONIC EXTENDED INFUSION SET UNO EWIS BLUE 60/6 HCAP 10PK INT FPA UNOMEDICAL A/S MMT-431A 6003116 05705244022683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown