Events

Safety Alert for DISPOSABLE TECHNICAL NEEDLE FOR ANESTHESIA - Registration: 10033430144, lots: 4222219 and 4217672

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
    809
  • Date
    2005-07-27
  • 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 arrange for the replacement of the units returned by others in accordance with the characteristic standard of the product. If you have any questions or concerns about this information, please contact your local representative or call the Customer Relationship Center at Tel.0800-555456. 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.
  • Reason
    Identification of less than normal luer taper.
  • Action
    Although minor taper does not prevent the use of the product, it should be tightened properly, requiring a 90 ° rotation during the connection between the syringe and the Spinal Needle Cannula. Reviews are being conducted with the mold suppliers to ensure proper preventative maintenance of the molds. Reviews are being conducted with the mold suppliers to ensure the tests performed using the ISO caliber. The areas of Quality Assurance and Projects are developing more sensitive test to detect possible leaks.

Device

DISPOSABLE TECHNICAL NEEDLE FOR ANESTHESIA - Registration: 10033430144, lots: 4222219 and 4217672

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda
  • Source
    ANVSANVISA