Events

Retiro De Equipo (Recall) de Chorion Villus Biopsy Needle Set

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook Australia 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-2018-RN-00835-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-06-26
  • 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-2018-RN-00835-1
  • 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
    Cook medical has identified the diagram on the product label of the chorion villus biopsy needle set (k-cvns-1821-robinson-et) is incorrect. it shows that the 18ga needle has an echotip, and the 21ga needle does not, whereas the product is designed such that the 21ga needle has the echotip and the 18ga needle does not.The tip of the larger gauge guide needle is likely to be visible on the ultrasound regardless of a non-echogenic tip. in the event that the labelling error resulted in a clinician expecting the echogenic tip to be present on the guide needle, instead of the sampling needle, the clinician may not be able to adequately identify the tip of the inserted access needle.To date, there have been no reports of harm relating to this issue.
  • Acción
    William A Cook is advising customers to inspect stock and return affected product.

Device

Chorion Villus Biopsy Needle Set
  • Modelo / Serial
    Chorion Villus Biopsy Needle SetCatalogue Identifier: K-CVNS-1821-ROBINSON-ETOrder Number: G26661All lots manufactured up to 4 June 2018ARTG Number: 138806(William A Cook Australia Pty Ltd - Chorionic Villi Biopsy Needle Set - Needle, biopsy, single use)
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd