BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I PORT ADVANCE

    MDR report key: 19510422 · Received June 11, 2024

    Report

    Report Number
    3003442380-2024-07664
    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 - MDR 3003442380-2024-07664 - DEVICE 1 OF 1. E1: 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 12-MAY-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
    1524693 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