BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19737199 · Received July 14, 2024

    Report

    Report Number
    3003442380-2024-14287
    Event Type
    Malfunction
    Date Received
    July 14, 2024
    Date of Event
    June 4, 2024
    Report Date
    July 14, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    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 1912344 - MDR 3003442380-2024 -14287 - DEVICE 1 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES, IT WAS REPORTED THAT THE FOUR INFUSION SET CANNULA WAS CRIMPED BETWEEN (B)(6) 2024 AND PATIENT FACES SYMPTOMS WITHIN 3 HOURS OF INSERTION. THE SITE OF INSERTION IS LEFT SIDE OF ABDOMEN AND INFUSION SET IS USED FOR 24-32 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499289 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6002511 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male