BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIO¿ DRUG RECONSTITUTION TRANSFER DEVICE

    MDR report key: 24050184 · Received January 12, 2026

    Report

    Report Number
    9617594-2026-00022
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    January 2, 2026
    Report Date
    March 10, 2026
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    LHI
    UDI-DI
    00887709120594
    PMA / PMN Number
    K192154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, HAS NOT BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    D9 - DATE RETURNED TO MFR: 1/12/2026. PHOTOS WERE RETURNED SHOWING FIBERS ON THE RIO AND A HAIR IN THE PACKAGING. RECEIVED ONE (1) OPEN/UNUSED VB-20 RIO DRUG RECONSTITUTION TRANSFER DEVICE FOR INSPECTION. THE SAMPLE WAS VISUALLY EXAMINED. TWO (2) SMALL FIBERS WERE FOUND ON THE VB-20. THE FIBERS WERE OUTSIDE OF THE FLUID PATH. THE REPORTED COMPLAINT CAN BE CONFIRMED. THE ROOT CAUSE OF THIS EVENT IS BEING INVESTIGATED UNDER CAPA-0010437. CORRECTIVE AND PREVENTIVE ACTIONS WILL BE DEFINED AND IMPLEMENTED BASED ON THE OUTCOMES OF THIS INVESTIGATION. THE LOT HISTORY WAS REVIEWED; NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) PLAN HAS BEEN IMPLEMENTED TO ADDRESS THE IDENTIFIED ISSUE. THE OUTCOME OF THE CAPA IS CURRENTLY UNDER EVALUATION AND IS NOT YET FINALIZED.

    Description of Event or Problem · 0

    AN EVENT INVOLVED A RIO TRANSFER DEVICE STATED THAT THE DEVICE HAS BLACK HAIRS ALONG BLUE SPIKE. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM / INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109860 RIO¿ DRUG RECONSTITUTION TRANSFER DEVICE SET, I.V. FLUID TRANSFER LHI ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14529909 00887709120594

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown