Events

Safety Alert for BD CATETER INTRAVENOUS CENTRAL HYDROCATH AND ACCESSORIES - Record: 10033430196 - Lots: 111121/111405/201348

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Becton Dickinson Indústrias Cirúrgicas 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
    806
  • Date
    2005-05-13
  • 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
    Due to market decisions, the product BD Catheter Central Intravenous HydrocathTM and Accessories was discontinued in the year 2000. Due to this, the registration was not revalidated with ANVISA, and its expiration in March 2004.
  • Reason
    Bd singapore (manufacturer) received 4 entries that the sealing of the primary packaging (tray versus cap) was incomplete, which could compromise the sterility of the product. it has been reported that bd singapore has not received any reports of increased infection rate related to the use of these products during the last 5 years. however, the evaluation of the manufacturing process identified a failure during packaging and, as a precautionary measure, the manufacturer is collecting all kits that were marketed after 1999, the date the current sealing process was implemented.
  • Action
    No action involving the aforementioned product, since, due to market decisions, the product BD Catheter Central Intravenous HydrocathTM and Accessories had its commercialization interrupted in the year 2000. Due to this the registration was not revalidated with ANVISA, with its maturity in March of 2004. (Registration holder information)

Device

BD CATETER INTRAVENOUS CENTRAL HYDROCATH AND ACCESSORIES - Record: 10033430196 - Lots: 111121/111...

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda
  • Source
    ANVSANVISA