Events

Retiro De Equipo (Recall) de Plastic Cannula – 11 gauge

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CareFusion Australia 316 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-01163-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-06
  • 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-01163-1
  • 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
    Becton dickinson (bd) has identified punctures in the blister packaging detected during the packaging process for specific lots of plastic cannula – 11 gauge.A breach in the sterile barrier has the potential to render the device non-sterile. it is possible end users may not detect the pin holes, thus utilising impacted product clinically. this could result in harm to patients especially when immunocompromised.In association with this recall, bd has decided to discontinue catalogue number: 9391-0200.To date, bd is not aware of any report of injury attributed to this defect in australia.
  • Acción
    1. Users are to discontinue use of and segregate the identified Lot Numbers of Catalogue Number 9391-0200 (Plastic cannula – 11 gauge). 2. Complete the supplied Customer Acknowledgement Form to confirm receipt of this notification. 3. Becton Dickinson is requesting that any impacted inventory be returned. 4. Becton Dickinson will arrange for the pick-up of your affected stock and issue a credit to your account.

Device

Plastic Cannula – 11 gauge
  • Modelo / Serial
    Plastic Cannula – 11 gauge Catalogue Number: 9391-0200Lot Numbers: 1470303001, 1470304601, 1470306301, 1470311301, 1470314801, 1570314802, 1570317701, 1570317702, 1570317704, 1570322001ARTG Number: 189737
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd