BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 24851030 · Received April 11, 2026

    Report

    Report Number
    3003442380-2026-85824
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Date of Event
    November 1, 2025
    Report Date
    March 13, 2026
    Manufacturer
    YPSOMED AG
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NAME: YPSOMED AG. COUNTRY: SWITZERLAND. STREET: (B)(6). CITY: (B)(6). ZIP CODE: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 8021545. MANUFACTURING SITE: 3003442380.

    Description of Event or Problem · 0

    THE TUBING BECAME DETACHED FROM THE TUBING CAP ON (B)(6) 2025, OCCURRING 2 DAYS FOLLOWING APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909310 INSET II Set, administration, intravascular FPA YPSOMED AG 86-046-52B6 6011180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown