Events

Retiro De Equipo (Recall) de Contact Detach Infusion Sets ( used in conjunction with a pump to deliver a continuous dose of insulin) Manufactured prior to May 2014

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Australasian Medical & Scientific 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-2015-RN-00703-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-31
  • 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-2015-RN-00703-1
  • 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 has identified a slight increase in reported cases of the steel needle breaking during use for infusions sets manufactured prior to may 2014. in a small sub set of these reported cases, this needle breakage has led to hospitalisation for the management of glucose levels and/or treatment for removal of the needle. needle breakage can result in the interruption of insulin delivery and can cause hyperglycaemia, which if left untreated, can result in diabetic ketoacidosis (dka). in addition to the interruption of insulin, a needle remaining in the body might, in rare cases, require surgical removal if the needle does not itself migrate to the surface where it can be removed with a pair of tweezers.
  • Acción
    In the event consumers wish to carry on with using the old needle they are reminded to follow the current IFU along with specific additional instructions in the customer letter; OR if they prefer users (including members of the public) can phone AMSL for replacement with unaffected stock. This action has been closed-out on 15/08/2016.

Device

Contact Detach Infusion Sets ( used in conjunction with a pump to deliver a continuous dose of in...
  • Modelo / Serial
    Contact Detach Infusion Sets ( used in conjunction with a pump to deliver a continuous dose of insulin)Manufactured prior to May 2014Multiple Lot Numbers – see attached listARTG Number: 116234
  • Manufacturer
    Australasian Medical & Scientific Ltd

Manufacturer

Australasian Medical & Scientific Ltd