BEUDAMED
    FDA Adverse Event Other Summary report: N

    AQUAVINE MIDLINE CATHETER

    MDR report key: 22220 · Received June 5, 1995

    Report

    Report Number
    MW1006146
    Event Type
    Other
    Date Received
    June 5, 1995
    Date of Event
    April 20, 1995
    Report Date
    June 1, 1995
    Manufacturer
    MENLO CARE, INC.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MMENLO CARE, INC. THIS DEVICE WAS NOT RETURNED BY THE CUSTOMER. SINCE THIS WAS AN ANONYMOUS REPORT, WE CANNOT VERIFY THAT THE EVENT DID OCCUR AS DESCRIBED. MANY PEOPLE WHO WITNESS SUCH AN EVENT TEND TO VIEW THE SYMPTOMS AS BEING CAUSED BY AN ALLERGY TO THE CATHETER MATERIAL; THEREFORE, WE PROVIDE INFO ON THE TESTING PERFORMED ON OUR MATERIAL THAT SHOWS IT UNLIKELY HTAT THE CAUSAL AGENT FOR THE EXPRESSION OF SUCH, SYMPTOMS IS A MATERIAL-HUMAN TISSUE INTERACTION ON AN IMMUNOLOGICAL LEVEL. IN ADDITION, WE PROVIDE INFO CONCERNING OTHER POSSIBLE CAUSAL AGENTS FOR THE EXPRESSION OF SUCH SYMPTOMS, SUCH AS HYPERVENTILATION, ANXIETY ABOUT A MEDICAL PROCEDURE, VASCULAR STIMULATION OR VENOUS IRRITATION DURING THE INSERTION OF THE DEVICE, AND SENSITIVITIES OR ALLERGIES TO FLUSH SOLUTIONS (EG, HEPARIN, PRESERVATIVES) SKIN PREPARATION MATERIALS (EG, POVIDONE IODINE), AND/OR DRUGS INFUSED THROUGH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUAVINE MIDLINE CATHETER MIDLINE CATHETER LYY MENLO CARE, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other