Events

Retiro De Equipo (Recall) de SANGOFIX IV Administration Set and HEIDELBERG EXTENSION TUBING SANGOFIX IV Administration 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 B Braun 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-2013-RN-01289-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-03
  • 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-2013-RN-01289-1
  • 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
    Following reports of leaking from the in-line safsite injection site, initial investigations have identified that on disconnection of a luer connector used to access the injection site, a resealing issue may occur intermittently. this may result in fluid leaking from the valve.
  • Acción
    As an interim corrective action, B.Braun is recommending that end users fit a stand-alone Safsite valve to the in-line injection site. The valve can be used for injection or infusion and does not need to be removed. Further notifications will be undertaken if any additional actions are required based on B. Braun's investigations.

Device

SANGOFIX IV Administration Set and HEIDELBERG EXTENSION TUBING SANGOFIX IV Administration Set
  • Modelo / Serial
    SANGOFIX IV Administration Set and HEIDELBERG EXTENSION TUBING SANGOFIX IV Administration SetArticle code: 4050193Batch number: 3H24278T34ARTG Number: 137615HEIDELBERG EXTENSION TUBINGArticle code: 4052197 Batch number: 3H21278A23ARTG Number:139265
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd