Events

Safety Alert for VENOUS CANAL SARNS / ANVISA Registry n ° 80012280001 ;. ARTERIAL CANAL SARNS / ANVISA Registry n ° 80012280011.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Terumo Cardiovascular System Corporation.

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
    1402
  • Date
    2014-07-25
  • 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 presence of loose fiber particles on the surface or within the cannula may be difficult to detect by users. Such particles may settle in the patient's vascular system, resulting in varying degrees of damage, depending on the size of the material, the location in which it was deposited, and the condition of the patient. Potential results include particle embolism or an inflammatory response that can cause blood clots, ischemia, or tissue death. #### UPDATED ON 08/18/2017, fieldwork documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Reason
    Presence of loose fiber particles that exceed terumo's finished product specifications.
  • Action
    Collection and destruction of the product. Users should stop using the products immediately, segregate them from their inventory quickly, and return them to distributors.

Device

VENOUS CANAL SARNS / ANVISA Registry n ° 80012280001 ;. ARTERIAL CANAL SARNS / ANVISA Registry n ...

Manufacturer

Terumo Cardiovascular System Corporation