BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I PORT ADVANCE

    MDR report key: 19510430 · Received June 11, 2024

    Report

    Report Number
    3003442380-2024-07665
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    May 12, 2024
    Report Date
    June 12, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244009394
    PMA / PMN Number
    K120337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1884809 - DEVICE 1 OF 1. PATIENT CITY: (B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN FINLAND. IT WAS REPORTED THAT PATIENT FACED FEW INFUSIONS SET CANNULA BENT EVENTS ON (B)(6) 2024. THE INFUSION SETS WAS IN USE FOR ONE TO TWO DAYS. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524700 I PORT ADVANCE I-PORT ADVANCE 6 MM FPA UNOMEDICAL A/S MMT-100 6004023 05705244009394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown