Events

Retiro De Equipo (Recall) de PhaSeal Secondary Set (C61)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Becton Dickinson 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-00834-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-25
  • 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-00834-1
  • 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 received reports of leakage which could result in the potential exposure of hazardous drugs to the healthcare worker during preparation, transport or administration.This defect was noted by customers during product use. leakage was observed between the connector to the secondary set spike and the tubing to the spike joint. the defect cannot be detected by visual inspection only. 8 reports relating to this issue have been received in australia. to date, no reports of injury have been received in australia.
  • Acción
    BD is advising customers to immediately review inventory and quarantine affected product. BD will arrange collection of affected stock from facilities.

Device

PhaSeal Secondary Set (C61)
  • Modelo / Serial
    PhaSeal Secondary Set (C61) Product code: 515302 Lot Number: 1005467 Distributed between 3/11/17 - 23/04/18ARTG Number: 299777(Becton Dickinson Pty Ltd - Basic intravenous administration set)
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd