Events

Retiro De Equipo (Recall) de Scalpel in Lifemed Procedure Packs

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bard 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-00267-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-20
  • 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-00267-1
  • 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
    Product complaints received by bard australia reported that the safety sheath covering the scalpel blade (component number in1951) was found in a very low number of lifemed procedure packs as being not engaged, resulting in an exposed blade that could inadvertently lead to a cut during manual handling by health care professionals, especially in circumstances where they are unaware of this anomaly whilst opening the pack.This issue does not impact the sterility of the packs.
  • Acción
    Users are being made aware of this issue and asked to take extra care when opening the procedure packs. Affected units may be returned at the discretion of the customer on a case by case basis.

Device

Scalpel in Lifemed Procedure Packs
  • Modelo / Serial
    Scalpel in Lifemed Procedure PacksComponent: IN1951Multiple Product Codes and Lot NumbersARTG Numbers: 180554 Bard Australia - Surgical procedure kit, general- purpose, single-use, non-medicated;180555 Bard Australia - Angiographic kit;189114 Bard Australia - Lifemed Angiography Pack with Guidewire - Angiographic kit; and193043 Bard Australia - Surgical procedure kit, general-purpose, single-use, non-medicated
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd