Events

Safety Alert for Spinocath - Spinal Anesthesia Kit Technical Name: Anesthesia Kit ANVISA Registration Number: 10008530204 Hazard Class: II Affected Model: 4517725 Serial numbers Affected: lot: 2I20018501

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Laboratórios B. Braun S.A.; B. Braun Melsungen AG.

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
    2119
  • Date
    2016-09-20
  • 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
    Interruption of the use of said lot, segregation thereof, information to B. Braun SA Laboratories of the quantities of existing units of this batch number for collection.
  • Reason
    It was identified the possibility of holes in the pvc film, responsible for performing a sterile barrier to the product spinocath g22. this type of orifice was verified in pvc film with thermoforming measuring 25mm. it is important to note that laboratorios b. braun sa canceled the registration of the item in question in 2014. however, it was identified the sale of 40 units of lot 2i20018501, (manufactured on 09/20/2012 and dated maturity for 09/2017) to a single customer, who had, in the year 2012, a relationship as distributor of products of b. braun sa.
  • Action
    Field Action Code AC / 02/2016 triggered under the responsibility of the company Laboratorios B. Braun SA Company will collect for further destruction.

Device

Spinocath - Spinal Anesthesia Kit Technical Name: Anesthesia Kit ANVISA Registration Number: 1000...

Manufacturer

Laboratórios B. Braun S.A.; B. Braun Melsungen AG