BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 19495763 · Received June 9, 2024

    Report

    Report Number
    3003442380-2024-07453
    Event Type
    Malfunction
    Date Received
    June 9, 2024
    Date of Event
    April 15, 2024
    Report Date
    June 9, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1883807 - DEVICE 3 OF 3 E1: PATIENT COUNTRY: UNITED STATES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT ENCOUNTERED THREE INFUSION SET CANNULA WERE CRIMPED WITHIN 3 HOURS OF INSERTION ON (B)(6) 2024. THE INSERTION SITE WAS AT SIDE OF ABDOMEN. THE SITE AREA IMPACTED BY CREATING A HOLE IN STOMACH. THE PATIENT CONFIRMED THAT THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION AND REGULARLY ROTATED THE SITE LOCATION. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123876 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male