Events

Safety Alert for Faucet 3 ways Descarpack - Registration 10330669026 - Affected lot TV0164.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Descarpack Descartaveis do Brasil 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
    1153
  • Date
    2012-07-23
  • 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 the patient being in use of vasoactive drugs, the leakage of the 3-way Faucet causes a smaller amount of medication administered, which in this case may result in hemodynamic instability in the patient. To reverse the condition, it would be necessary to increase the amount of vasoactive drugs administered. # UPDATED ON 7/8/2012: REPLACEMENT OF THE BATCH NUMBER. THIS IS THE LOT TV0164 ##### CLOSED ####
  • Reason
    The 3-way tap presented medication leakage, through its central part, in a postoperative patient of aortic valve replacement surgery.
  • Action
    It is recommended that the health care team check the 3-way Faucet for possible leakage of solutions through the central portion of the same. Extravasation, when it occurs, can be easily visualized. Avoid use; segregate the material in your inventory and communicate to the supplier for collection and exchange.

Device

Faucet 3 ways Descarpack - Registration 10330669026 - Affected lot TV0164.

Manufacturer

Descarpack Descartaveis do Brasil Ltda.