BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 13897008 · Received March 24, 2022

    Report

    Report Number
    3003442380-2022-00431
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Report Date
    March 25, 2022
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT SUDDENLY NOTICED THAT HER INFUSIONS SET WAS BROKEN IN THE PART OF THE TUBE THAT WAS CONNECTED TO THE ATTACHMENT. THE INFUSIONS SET WAS INSERTED ON HER STOMACH ACCORDING TO GUIDELINES 6 HOURS BEFORE. HOWEVER, SHE HAD TO INSERT A NEW INFUSION SET. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106450 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA 1002817 5351829 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown