Events

Retiro De Equipo (Recall) de POINTGUARD BIONIC Safety Needles

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Bionic Medizintechnik GmbH.

¿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
  • Fecha
    2008-06-06
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-tous-les-lots-d-aiguilles-securisees-pointguard-bionic-fresenius-medical
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    Afssaps has been informed that Fresenius Medical Care has withdrawn from the market on May 30, 2008, all batches of all references, the medical device called "POINTGUARD BIONIC Safety Needles" manufactured by Bionic Medizintechnik GmbH, following reports mentioning removal of the fistula needle from the puncture site, resulting in blood loss to the patient during dialysis. Fresenius Medical Care has directly notified the recipients of the offending lots with the attached message (06/06/2008) (200 KB). This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

POINTGUARD BIONIC Safety Needles

Manufacturer

Bionic Medizintechnik GmbH