BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANES DELY SET W/ 3 Y'S

    MDR report key: 166838 · Received May 5, 1998

    Report

    Report Number
    1627487-1998-00017
    Event Type
    Malfunction
    Date Received
    May 5, 1998
    Date of Event
    April 1, 1998
    Manufacturer
    QMI MEDICAL, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MANIFOLDS ARE ALLOWING RETROGRADE FLOW INTO THE IV BAG. THE MANIFOLD IS INVERTED WHEN PRIMED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANES DELY SET W/ 3 Y'S ANESTHESIA DELIVERY SET CAI QMI MEDICAL, INC. 9642 8611.X08

    Patients

    Seq Age Sex Outcome Treatment
    1 *