Events

Retiro De Equipo (Recall) de Veletri Consumables Kit - Infusion administration set containing B. Braun Water for Injections

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Actelion Pharmaceuticals 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-2016-RN-00147-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-09
  • 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-2016-RN-00147-1
  • 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
    Complaints have been received regarding leakage and under-filling of ecoflac plus bottles with cracks at the transition from the container shoulder to the container body. this may result in microbial contamination of the product and pose a risk to patients.
  • Acción
    The sponsor is advising users to inspect stock and quarantine the affected kits prior to their return. Until replacement kit is received, patients are recommended to use an alternative unaffected water for injection product. If this is not available, patients should check each bottle of water carefully before use to ensure the container and its closure or packaging are undamaged. DO NOT use the bottle if a leak has been noticed. This action has been closed-out on 03/02/2017.

Device

Veletri Consumables Kit - Infusion administration set containing B. Braun Water for Injections
  • Modelo / Serial
    Veletri Consumables Kit - Infusion administration set containing B. Braun Water for Injections Lot Number: 14217404 (B. Braun Water for Injections)Batch numbers: 0309757 and 0309991 (Veletri Consumables Kit)Expiry Date: 2017-04ARTG Number: 219458
  • Manufacturer
    Actelion Pharmaceuticals Australia Pty Ltd

Manufacturer

Actelion Pharmaceuticals Australia Pty Ltd