Events

Retiro De Equipo (Recall) de Premicath Neonatal PICC with Stylet Premicath with Stylet

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-2018-RN-00478-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-07-05
  • 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-2018-RN-00478-1
  • 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
    Device technologies australia (dta) has been made aware by the manufacturer, vygon gmbh & co kg, of reported incidents where the stylet snapped upon removal when the user made a second attempt to remove the stylet from the catheter.
  • Acción
    DTA is advising that the Instructions for Use (IFU) has been revised to provide further instructions concerning the removal of the Stylet. The relevant segment is as follows: "In order to remove the stylet, disconnect between the T-Piece and catheter hub. If difficulty is experienced stop, let vein rest for a minute and try removal again very slowly. Gentle flushing of the catheter with diluted lipid solution (preferred) or saline assists in stylet removal. If resistance still remains, withdraw catheter and stylet simultaneously."

Device

Premicath Neonatal PICC with Stylet Premicath with Stylet
  • Modelo / Serial
    Premicath Neonatal PICC with Stylet Premicath with Stylet Product Code: VY-1261.153 Premicath 1FR 20cm Split NeedleProduct Code: Vy-1261.203 Premicath with Stylette Product Code: VY-1261.205 Premicath W Pink Hub Secure Device Product Code: VY-1261.207 Premicath 1FR 28g 30cm w/stylet Product Code: VY-1261.306 ARTG Number: 141227(Device Technologies Australia Pty Ltd - Catheter, intravascular, general-purpose)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd