Events

Safety Alert for BD EXACTA - INTRODUCTORY KIT OF ARTERIAPULMONAR CATETER - Registration: 10033430274 - Lots: 309420/406463/311610/311609/311197/406462 /. 311612/309419/309418/380187/406374

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
    807
  • 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
    It is important that the following actions are taken: 1. Identify whether you are using or have stock of the products according to the batches indicated; 2. Discontinue use immediately and block stock; This product will be collected and replaced by your distributor; 3. Complete the Fonnary sent by the company; 4. Return the completed form to the BD, through your distributor or by fax (11) 5185.9642 (BD). If you have any questions or concerns about this information, please contact your local representative or call the Customer Relationship Center at Tel.0800-655654. ANVISA will be accompanying the actions that will be carried out through the company regarding the whole process of collection and replacement of said product. xxxxx The company informs the closing of the collection process, that is, all existing material in the Brazilian Market was collected and replaced.
  • 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
    BD Singapore is reviewing the sealing process in order to correct the flaw. In the meantime, the visual inspection of 100% of the units was introduced in the manufacturing and packaging process. In Brazil Although no adverse events have been reported with the use of any unit of these batches, BD requests that the use of the product BD EXACTA - CATTERY INTRODUCTOR KIT OF ARTERIAPULMONAR - Registration: 10033430274 - Lots: 309420/406463/311610/311609 / 311197/406462 / 311612/309419/309418/380187/406374 is interrupted and the drives are returned. The company will arrange for the replacement of units returned by others in accordance with the kit's characteristic standard.

Device

BD EXACTA - INTRODUCTORY KIT OF ARTERIAPULMONAR CATETER - Registration: 10033430274 - Lots: 30942...

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda.
  • Source
    ANVSANVISA