Events

Retiro De Equipo (Recall) de MobiCath Bi-Directional Guiding Sheath, Small Curve(used to introduce cardiovascular catheters)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00278-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-28
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00278-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer, greatbatch medical has received reports of a pouch seal integrity issue with a specific lot of mobicath bi-directional guiding sheath. one side of the pouch may not be sealed and as a result, may cause the sterile barrier of the pouch to be compromised. the use of a non-sterile product in surgery could potentially result in adverse health consequences, such as infection, which could lead to life threatening events and/or death. greatbatch has received no reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.
  • Acción
    JJM is advising users to immediately inspect the device(s) in their possession to determine if their facility has affected product, and then to quarantine the affected product prior to returning it to JJM for replacement.

Device

MobiCath Bi-Directional Guiding Sheath, Small Curve(used to introduce cardiovascular catheters)
  • Modelo / Serial
    MobiCath Bi-Directional Guiding Sheath, Small Curve(used to introduce cardiovascular catheters)Product Number: D140010Lot Number: W3338707ARTG Number: 191013
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd