Events

Alerte De Sécurité sur Central Venous Catheter Double Lumen, 4Fx13cm, Model CS-14402, Registration No. 10216830011, lot: RF1069600.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Gabmed Produtos Específicos Ltda..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1220
  • Date
    2013-01-09
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    According to the manifestation of the company, the use of the product with deviation of the quality can cause in the stay of part of the guidewire within the vein of the patient. The company requests to observe the batch number of the products in stock and, if the lot involved in the collection, please contact the distributor. Email to contact: calidad@gabmed.com.br####ERROR: 02/20/2013 - The company forwards documentation of the destruction of the collected products, thus finalizing this field action. ####
  • Cause
    The company holding the registry has identified recurrence in reports describing that the catheter guidewire has ruptured.
  • Action
    The company that owns the registration in Brazil is collecting the product. The collected parts will be segregated until the manufacturer's report (International Arrow, located in the United States) is delivered and the company can decide on the final destination of the products collected.

Device

Central Venous Catheter Double Lumen, 4Fx13cm, Model CS-14402, Registration No. 10216830011, lot:...

Manufacturer

Gabmed Produtos Específicos Ltda.