Events

Retiro De Equipo (Recall) de Perifix Catheter Connector Perifix Complete Set (Lor) Soft-Tip Perifix One Complete Set Perifix One Complete Set (Lor)Espocan W. Ds + Pencan 27gx5 3/8" (0,42xEspocan W. Ds + Pencan 27gx5 3/8" (0,42xEspocan W. Ds + Pencan 27gx5 3/8" (0,42xPerifix One Paed Set 18 Contiplex D Set,15°,18gx2 1/8", 1.3x55mm Cont S Ult 360,20°18gx100mm-Cis/Ap/Eu/SaCont. Tu. Ult 360,18gx100mm-Cis/Ap/Eu/Sa

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por B Braun 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-00928-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-07-09
  • 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-00928-1
  • 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
    The perifix catheter connector is a connection device used by clinicians to provide various anaesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anaesthetics. in the course of our regular post market surveillance activities we have found that the perifix catheter connector may not remain closed during use. in some cases this has led to leakage or disconnection of the catheter from the perifix catheter connector. while no serious injuries to patients, users, or third parties have been reported to date, there is a possibility of contamination of the catheter or delay of anaesthesia of different severity.
  • Acción
    Users are asked to: Review the customer letter in its entirety and ensure that all users of these products in your organization and other concerned persons are informed about this Medical Device Correction. If you are a distributor, please forward the customer letter to your customers. For continued safe use of the Perifix Catheter Connector, users are asked to review and follow the instructions described in Appendix 1 of the customer letter. Confirm receipt of the customer letter by completing the supplied confirmation slip and return it as per the instructions given.

Device

Perifix Catheter Connector Perifix Complete Set (Lor) Soft-Tip Perifix One Complete Set Perifix O...
  • Modelo / Serial
    Perifix Catheter ConnectorPerifix Complete Set (Lor) Soft-TipPerifix One Complete SetPerifix One Complete Set (Lor)Espocan W. Ds + Pencan 27gx5 3/8" (0,42xEspocan W. Ds + Pencan 27gx5 3/8" (0,42xEspocan W. Ds + Pencan 27gx5 3/8" (0,42xPerifix One Paed Set 18Contiplex D Set,15°,18gx2 1/8", 1.3x55mmCont S Ult 360,20°18gx100mm-Cis/Ap/Eu/SaCont. Tu. Ult 360,18gx100mm-Cis/Ap/Eu/SaMultiple Product Codes and Batch NumbersARTG Numbers: 143519, 144119 and 138970
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd