BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YPSOMED AG

    MDR report key: 20703587 · Received November 18, 2024

    Report

    Report Number
    3003442380-2024-31980
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 21, 2024
    Report Date
    October 21, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED KINKED CATHETER EVENT ON (B)(6) 2024. THE INFUSION SET WAS INSERTED IN ABDOMEN. COMPANY DO NOT SEE 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2610998 YPSOMED AG UNO INSET II 46/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL A/S 86-046-52B6 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown