Events

Safety Alert for Trade Name: Percutaneous Access Set Aprima - Reg.10212990312 - Class II-medium risk; presentation NPAS-104-HC-NT-U-SST. COMPONENTS OF THE ASSEMBLY: ACCESS NEEDLE, GUIDE WIRE, RIGID SHAFT AND INTRODUCING SHAFT; Lots 5146406; 5,146,407; NS5469904; NS5469905.

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
    1894
  • 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
    Customer Guidelines: 1) Please review the list of affected lots and confirm the company E. Tamussino & Cia Ltda if these items are still physically in their inventory, then the items should be immediately segregated; 2) Contact E. Tamussino & Cia Ltda so that they can align the return of these catheters; 3) Circle this Recall Notice internally for all interested / affected parties; 4) Inform E.Tamussino if any of the devices mentioned in this notice have been distributed to other organizations. 5) Please provide contact details so that E.Tamussino can inform recipients accordingly. 6) If you are a Distributor, please note that you are responsible for notifying your affected customers. 7) Please fill out the form attached to the customer communication letter and send it by e-mail within 7 days from the receipt of this notice to the technical heads of the State for which you are served. Inquiries regarding this field action should contact E. Tamussino & Cia. Ltda by telephone (21) 3221-8570.
  • Reason
    Cook medical, the manufacturer of the product, is voluntarily recalling specific batches. a degradation of the polymers forming the tip of the catheter has been identified which results 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 obstruction of blood flow to the terminal organs.
  • Action
    Action code T10071-32, T10071-34, T10071-35, T10071-36, T10071-37, T10071-38, T11747-3, T11747-6, T11747-8. Customer orientation /////// Gathering.

Device

Trade Name: Percutaneous Access Set Aprima - Reg.10212990312 - Class II-medium risk; presentation...

Manufacturer

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