BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 19446757 · Received June 3, 2024

    Report

    Report Number
    8021545-2024-00820
    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 2 OF 3. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: CANADA.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED ON 30-APR-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
    594973 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