BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 19737259 · Received July 14, 2024

    Report

    Report Number
    3003442380-2024-14423
    Event Type
    Malfunction
    Date Received
    July 14, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 14, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018365
    PMA / PMN Number
    K061374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1912497 - MDR 3003442380- 2024 -14423 - DEVICE 6 OF 9

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN, IT WAS REPORTED THAT THE NINE INFUSION SET CANNULA WAS KINKED ON (B)(6)2024, (B)(6)2024, (B)(6)2024, (B)(6)2024,(B)(6)2024, (B)(6)2024, (B)(6)2024, (B)(6)2024, (B)(6)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
    210905 AUTOSOFT 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002825 6004750 05705244018365

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown