BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-CATH

    MDR report key: 16311 · Received January 24, 1994

    Report

    Report Number
    16311
    Event Type
    Injury
    Date Received
    January 24, 1994
    Date of Event
    August 17, 1993
    Report Date
    September 23, 1993
    Manufacturer
    HDC CORPORATION
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT IS ONE OF FOUR WHO DEVELOPED A PLEURAL EFFUSION DURING THE USE OF THIS DEVICE. THE ONLY COMMON LINK BETWEEN THESE FOUR PATIENTS, OTHER THAN SEX, IS THE USE OF THIS PRODUCT. ALTHOUGH IT CANNOT BE STATED WITH ABSOLUTE CERTAINTY THAT THE CATHETER CAUSED THE PLEURAL EFFUSIONS, THE CIRCUMSTANTIAL EVIDENCE WAS ISGNIFICANT ENOUGH THAT THE MEDICAL DIRECTOR HAS DISCONTINUED THE USE OF THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH CENTRAL VENOUS CATHETER DQO HDC CORPORATION 350-00 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DAY Hospitalization| L| R