BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTICAL MOUNT MANIFOLD FOR DUKE UNIVERSITY

    MDR report key: 16096146 · Received January 4, 2023

    Report

    Report Number
    9617594-2023-00005
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    December 13, 2022
    Report Date
    December 13, 2022
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619068943
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF BLUE PARTICLE INSIDE THE TUBING WAS CONFIRMED ON THE RETURNED SET. THREE (3) IMAGES WERE PROVIDED BY THE CUSTOMER SHOWING THE BLUE PARTICULATE INSIDE THE TUBING. DURING VISUAL INSPECTION, A BLUE PARTICULATE WAS OBSERVED INSIDE THE TUBING. WHEN THE MANIFOLD HANDLES WERE POPPED OUT OF THE MANIFOLD, FLASH WAS OBSERVED ON ONE OF THE HOLES OF THE MANIFOLD HANDLE. THE BLUE PARTICLE OBSERVED IN THE TUBING IS A PART OF THE MANIFOLD HANDLE. THE PROBABLE CAUSE OF THE FLASH ON THE MANIFOLD HANDLE HAD OCCURRED DUE TO AN ERROR DURING MOLDING AT MANUFACTURING PLANT. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, TESTING HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A VERTICAL MOUNT MANIFOLD. IT WAS REPORTED THROUGH VISUALIZATION THAT BLUE PARTICULATE WAS IN TUBING WHEN REMOVED FROM WRAP PRIOR TO USE. NO REPORT OF PATIENT HARM WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908238 VERTICAL MOUNT MANIFOLD FOR DUKE UNIVERSITY STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 46056=37 6077767 00840619068943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown