BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-SET

    MDR report key: 370325 · Received October 31, 2001

    Report

    Report Number
    9611004-2001-00001
    Event Type
    Other
    Date Received
    October 31, 2001
    Manufacturer
    GO MEDICAL INDUSTRIES PTD. LTD.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    NO PRODUCT PROBLEM. NOTE: A MEDICAL PRACTITIONER IN A FOREGIN COUNTRY CONNECTED A CLAVE CONNECTOR TO THE V-SET AND THE FLOW STOPPED. THE INSTRUCTIONS FOR USE STATES THAT THE V-SET IS TO BE CONNECTED TO AN IV CANNULA. AS SUCH THE MEDICAL PRACTITIONER DEVIATED FROM THE CORRECT USE OF THE V-SET. THERE WERE NO DEFECTS OF THE V-SET. IF THE V-SET HAD NOT BEEN CONNECTED TO THE CLAVE CONNECTOR, THERE WOULD HAVE BEEN NO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49512 V-SET * FPA GO MEDICAL INDUSTRIES PTD. LTD. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CLAVE CONNECTOR