Events

Retiro De Equipo (Recall) de Neria Infusion 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 Clinect 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-2015-RN-00536-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-03
  • 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-2015-RN-00536-1
  • 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 of the product, unomedical a/s has found that in rare cases the steel needle can break during use, interrupting the delivery of medication. if the needle breaks during use, the delivery of medicine will be interrupted and the patient may experience a range of symptoms depending on therapy area and medication used. additionally, if a broken needle remains in the body, it can lead to infection which, in rare cases, might require surgical removal.
  • Acción
    Clinect is notifying patients of the issue and providing instruction to ensure the safe use of the devices, however, should patients wish to return the device this can be arranged through their supplier. Clinect is also recovering potentially affected stock from hospitals, retailers and distributors. This action has been closed-out on 12/08/2016.

Device

Neria Infusion Administration Set
  • Modelo / Serial
    Neria Infusion Administration Set Models : G27-6mm-60cm, G27-8mm-80cm, G27-10mm-80cm and Multi 2 G27-8mmRef. numbers: 78-060-2736, 78-080-2738, 78-080-2731 and 721060-2738Lot numbers: 5017071, 5024517, 5033612, 227979, 227980, 5006113, 5006114, 5006115, 5028915, 5063419, 5020514, 5022947, 5033623, 5063787ARTG number: 198459
  • Manufacturer
    Clinect Pty Ltd

Manufacturer

Clinect Pty Ltd