Events

Retiro De Equipo (Recall) de 4FR Single Lumen Pressure Injectable Peripherally Inserted Central Catheter (PICC)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Teleflex Medical 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-2015-RN-00915-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-09-15
  • 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-00915-1
  • 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
    There is a labelling inaccuracy in the instructions for use (ifu) and injection card. the ifu and the injection card contained within the product states that picc testing included 10 pressure injection cycles. this is not correct, it should state that catheter testing included only 5 pressure injection cycles.If it were to be used for more than five (5) pressure injections, it cannot be ruled out that there is a potential risk that the catheter could rupture during injections 6-10. catheter rupture can cause catheter or air embolism, bleeding or ineffective treatment and may require the need for radiologic or surgical intervention. no customer complaints have been received for this issue.
  • Acción
    Customers are notified not to use the device for more than five pressure injections. Future stock will have the IFU and injection card amended to reflect this change. This action has been closed-out on 26/08/2016.

Device

4FR Single Lumen Pressure Injectable Peripherally Inserted Central Catheter (PICC)

Manufacturer

Teleflex Medical Australia Pty Ltd