Events

Safety Alert for SHER-I-BRONCH ENDOBRONCHIAL TUBE - Registered in Anvisa under the number 10342600018 - Models / Lots: See attached list.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Comercial Nacional de Produtos Hospitalares Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    977
  • Date
    2009-08-31
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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.