Events

Alerte De Sécurité sur SHER-I-BRONCH ENDOBRONCHIAL TUBE - Registered in Anvisa under the number 10342600018 - Models / Lots: See attached list.

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 Comercial Nacional de Produtos Hospitalares 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
    977
  • Date
    2009-08-31
  • 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
    Manufacturing problems were identified as of July / 2009. In Brazil no cases of adverse events involving this product have been reported up to the present moment. The completion of the collection action of this product is scheduled for October / 2009. Anvisa follows this action.
  • Cause
    The product manufacturer has announced that the plastic connection connecting the cover to the sher-i-swiv double swivel body may break partially or completely at certain points. breakage of this connection can cause it to be thrown into the tube or double swivel body, resulting in potential accidental aspiration of the part into the patient's lungs.
  • Action
    The actions recommended to product users are as follows: (1) Find the products with the affected models / batches in your inventory and segregate them. (2) Return them to the dealer for disposal. (3) Contact the representative in Brazil: Comercial Nacional de Produtos Hospitalares Ltda. - Anny Caroline Di Rocco Santos - Phone: (011) 3385-9361 - e-mail: any@cnph.com.br.

Device

SHER-I-BRONCH ENDOBRONCHIAL TUBE - Registered in Anvisa under the number 10342600018 - Models / L...

Manufacturer

Comercial Nacional de Produtos Hospitalares Ltda.