Events

Retiro De Equipo (Recall) de ARROW PICC Kits with Peel-Away Sheath Component

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-2017-RN-00408-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-04-05
  • 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-00408-1
  • 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
    Arrow international has received complaints related to peel away sheath flare for the arrow picc kits. the instructions for use included with the kits do not inform the user that a skin nick or alternate enlargement method may be required for difficult insertions. the use of a skin nick reduces the possibility of sheath flare and subsequent complications. there is a remote possibility the device may cause a delay in treatment or minor damage to the vessel wall or subcutaneous tissue.
  • Acción
    Teleflex is advising users that they may be required to use an alternate enlargement method or perform a skin nick for difficult insertions. Customers are also requested to include the supplementary card (Product Notice) with their affected stock.

Device

ARROW PICC Kits with Peel-Away Sheath Component
  • Modelo / Serial
    ARROW PICC Kits with Peel-Away Sheath ComponentCatalogue Numbers: PI-01351-LS, PI-01351-SS, PI-01451-LS, PI-01451-SS, PI-01552-LS, PI-01552-SS, PR-05041, PR-05041-T, PR-05042, PR-05052, PR-05052-MWMultiple Lot NumbersARTG Numbers: 148783 and 148784
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd