BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS® CLOSED MALE LUER, RED CAP

    MDR report key: 23471766 · Received November 4, 2025

    Report

    Report Number
    9617594-2025-02124
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 14, 2025
    Report Date
    December 1, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619026615
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT COULD NOT BE CONFIRMED BY INVESTIGATION. NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    K082806.

    Description of Event or Problem · 0

    AN EMAIL WAS RECEIVED REGARDING A SPINNING SPIROS® CLOSED MALE LUER, RED CAP, ALLEGING A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THE PRODUCT LEAKED DURING CHEMO INFUSION. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM REPORTED, BUT A DELAY IN THERAPY; THEY HAD TO REMAKE THE CHEMO AND THE ADMINISTRATION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478469 SPINNING SPIROS® CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN 00840619026615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED CHEMO, UNK MFR