Events

Retiro De Equipo (Recall) de Secondary Set Oncology

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CareFusion Australia 316 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-00465-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-10
  • 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-00465-1
  • 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, becton dickenson (bd) has received reports of cracking of the secondary set back check valve male luer resulting in leaking of the infusion fluid. during use of the set, a leak occurs at the connection between the needle free valve and back check valve (bcv) connection. leakages can cause delay of infusion, interruption of infusion, exposure to infusates, or under-infusion. bd has not received any reports of serious injury or death associated with the separation or leaks. bd is not aware of any report of injury attributed to this defect in australia.
  • Acción
    BD is advising users to discontinue use of and segregate the identified units, and then return to BD. Replacement stock or credit will be provided.

Device

Secondary Set Oncology
  • Modelo / Serial
    Secondary Set Oncology Catalogue Number: 72951NE Lot Numbers: 1000089, 1000129, 1000208, 1000468, 1000469, 1000687 and 1000713ARTG Number: 125916
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd