BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 19446772 · Received June 3, 2024

    Report

    Report Number
    8021545-2024-00819
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    April 30, 2024
    Report Date
    June 3, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244023314
    PMA / PMN Number
    K210544
    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 1 OF 3. (B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED ON (B)(6) 2024 THAT THE PATIENT EXPERIENCED ISSUES WITH THREE INFUSION SETS. THE INFUSION SETS LEAKED DURING BOLUS ADMINISTRATION, AND LEAKAGE MAY HAVE OCCURRED AT THE QR/CONNECTOR OR AT THE SITE. THE EVENTS OCCURRED ON 30-APR-2024, 31-APR-2024 AND 03-MAY-2024. THE INFUSION SETS WERE IN USE FOR A DURATION OF THREE DAYS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629576 MEDTRONIC EXTENDED UNO EWIS BLUE 80/9 HCAP 3-PK INT FPA UNOMEDICAL A/S MMT-442AH 6003590 05705244023314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown