BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19737254 · Received July 14, 2024

    Report

    Report Number
    3003442380-2024-14428
    Event Type
    Malfunction
    Date Received
    July 14, 2024
    Date of Event
    April 1, 2024
    Report Date
    July 14, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1912498 - MDR 3003442380- 2024 -14428 - DEVICE 2 OF 5.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN, IT WAS REPORTED THAT THE FIVE INFUSION SET CANNULA WAS KINKED ON 01-APR-2024, 09-APR-2024, 19-APR-2024, 23-MAY-2024 & 29-MAY-2024 AND PATIENT FACES SYMPTOMS WITHIN 3 HOURS OF INSERTION. THE INFUSION SET IS USED FOR FEW HOURS. 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
    209919 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6003209 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown