Events

Safety Alert for Product name: PERCUTANEOUS ACCESSORY ASSEMBLY (ANVISA registration number: 10212990312) /// Affected model (s): NPAS-104-HC-NT-U-SST /// Product hazard class: II.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by E. TAMUSSINO & CIA. LTDA.; COOK INCORPORATED..

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
    1895
  • Date
    2016-05-10
  • 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
  • Reason
    The company reports that "a degradation of the polymers forming the tip of the catheter has been identified resulting in the division or separation of the catheter tip. potential adverse events may occur as a result of degradation of the catheter tip polymer and these effects include: loss of device function, separation of a segment from the device, and may lead to medical intervention to recover separate segment, or complications resulting from this separation in the system as an obstruction of blood flow to the terminal organs. ".
  • Action
    Classification of risk: III /// Classification of the field action: collection with subsequent return to the manufacturer /// Field action code: T10071-32, T10071-34, T10071-35, T10071-36, T10071-37, T10071-38, T11747-3, T11747-6, T11747-8 /// Recommendations to users and patients: A) Analyze whether these recall items are still physically in their inventory, then items should be immediately segregated; b) Contact E. Tamussino & Cia Ltda so that we can align the return of these catheters; c) Circulate the Recall Notice internally for all interested / affected parties; d) Inform E.Tamussino if any of the devices mentioned in this notice have been distributed to other organizations. Please provide contact details so that E.Tamussino can inform recipients accordingly; e) If you are a Distributor, please note that you are responsible for notifying your affected customers.

Device

Product name: PERCUTANEOUS ACCESSORY ASSEMBLY (ANVISA registration number: 10212990312) /// Affec...

Manufacturer

E. TAMUSSINO & CIA. LTDA.; COOK INCORPORATED.
  • Source
    ANVSANVISA