Events

Safety Alert for SFN PUNCH NEEDLE FOR TOTALLY IMPLANTABLE CATHETER SYSTEM - Registered at Anvisa under the number 10342600035 - Model SFN-A 0925 - Lot 09468.

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
    982
  • Date
    2009-09-21
  • 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
    The company informs that it has so far received no reports of adverse events related to the problem described. The cause of the problem is still under investigation. Anvisa is following this action.
  • Reason
    The company reports that, through customer complaints, it has been verified that there is a possibility that the stent will detach itself from the needle during its use and may cause potential harm to patients.
  • Action
    The actions performed by the company were: (1) Tracking of affected lots traded; (2) Segregation of affected lots from stock; (3) Communication to customers. The actions recommended to users of the product are as follows: (1) Immediately stop the use of affected products; (2) Identify and segregate the affected products in their inventories; (3) Report the distributors or the holder to the collection - Mrs. Anny Caroline Camargo Di Rocco Santos - Fax 011-3385-9362 or by e-mails anny@cpnh.com.br and sac@cpnh.com.br

Device

SFN PUNCH NEEDLE FOR TOTALLY IMPLANTABLE CATHETER SYSTEM - Registered at Anvisa under the number ...

Manufacturer

COMERCIAL NACIONAL DE PRODUTOS HOSPITALARES LTDA.