Events

Retiro De Equipo (Recall) de Encore 26 Inflation Device Single Pack

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Boston Scientific 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-00795-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-21
  • 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-00795-1
  • 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
    Boston scientific has received reports of cracking with specific lots of encore 26 inflation device single packs. the device trays from these lots have the potential to crack under certain handling conditions, such as impact during shipment. this issue has been attributed to a change in the material used in the packaging process. use of an encore device with a cracked device tray during a procedure could result in patient infection if used within the sterile field. to date, no reports of patient harm have been received.
  • Acción
    Boston Scientific is requesting that Customers: 1. Immediately check inventory and identify whether there are products with UPNs and lot numbers listed in Attachment 1 of the customer letter; 2. Inspect the device tray in the area highlighted above. If you identify any units with a cracked tray in your supply, immediately discontinue use and segregate affected units in a secure location; and 3. Complete the Reply Verification Tracking Form detailing identified affected units.

Device

Encore 26 Inflation Device Single Pack
  • Modelo / Serial
    Encore 26 Inflation Device Single PackUPN: H74904526011, M001151050, M00566670 and M0067101140 Multiple Lot NumbersARTG Number: 137086
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA