BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOFT

    MDR report key: 20200379 · Received September 12, 2024

    Report

    Report Number
    8021545-2024-03650
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    July 9, 2024
    Report Date
    August 16, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018693
    PMA / PMN Number
    K162812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1970544 - MDR DEVICE 1 OF 4.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT, THE PATIENT EXPERIENCED ISSUE WITH 4 INFUSION SETS CANNULA BEING KINKED ON (B)(6) 2024. THE SET WAS FOUND TO BE KINKED WITHIN 3 OR MORE HOURS OF INSERTION, AFTER BEING IN USE FOR 24-48 HOURS. THE SITE OF INSERTION WAS LOCATED AT ABDOMEN. FURTHERMORE, THE PATIENT CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. COMPANY 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
    504909 VARISOFT UNO COMFORT SHORT 60/13 TCAP 10PK INT FPA UNOMEDICAL A/S 1002827 6005452 05705244018693

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female