Alerta De Seguridad para Product name: PERCUTANEOUS ACCESSORY ASSEMBLY (ANVISA registration number: 10212990312) /// Affected model (s): NPAS-104-HC-NT-U-SST /// Product hazard class: II.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por E. TAMUSSINO & CIA. LTDA.; COOK INCORPORATED..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1895
  • Fecha
    2016-05-10
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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. ".
  • Acción
    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.

Manufacturer