Events

Safety Alert for Locking Titanium Adapter for Peritoneal Dialysis Catheter (Anvisa Registry # 10068390171); 6 "Transfer Kit with Long Stay Twist-Clamp (Anvisa Registration No. 10068390005); Prep Kit for CAPD-SDD (Anvisa Record 10068390336).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BAXTER HOSPITALAR 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
    1503
  • Date
    2015-02-04
  • 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 will add a phrase in the instructions for use of the disconnection systems, warning that the product should not be used in patients with a known history of allergic reactions to iodine. Check full information in the alert message published by the company, available at: http://portal.anvisa.gov.br/wps/wcm/connect/99fa2e00472fc243aafebbbb1e455ac3/Carta+ao+Cliente.pdf?MOD=AJPERES
  • Reason
    Warning about the need to observe the situation of iodine allergy in the patient undergoing peritoneal dialysis, using any of the products mentioned in this alert.
  • Action
    The products in question should not be used during therapy (peritoneal dialysis) in patients with a history of iodine allergy. The company is sending customers a safety alert with an update of the instructions for use.

Device

Locking Titanium Adapter for Peritoneal Dialysis Catheter (Anvisa Registry # 10068390171); 6 "Tra...

Manufacturer

BAXTER HOSPITALAR LTDA.