Events

Retiro De Equipo (Recall) de VenoCath Drum Cartridge Catheter (intravascular catheter)

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

¿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-2012-RN-00959-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-09-25
  • 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-2012-RN-00959-1
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
  • Causa
    Hospira has received reports from customers of drum cartridge catheter reports of the drum catheter dismantling/uncoiling before or during use/insertion. there have been complaints related to difficulty in inserting the catheter, leaks and separations, breakage of the catheter inside patient during insertion.
  • Acción
    Hospira is asking customers to immediately quarantine and return the affected stock for credit. Hospira is not going to continue to supply this product and is suggesting customer identify alternative products.

Device

VenoCath Drum Cartridge Catheter (intravascular catheter)
  • Modelo / Serial
    VenoCath Drum Cartridge Catheter (intravascular catheter)List Number: 100G8920610H1ARTG Number: 161905
  • Manufacturer
    Hospira Pty Limited

Manufacturer

Hospira Pty Limited
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    DHTGA