Events

Alerta De Seguridad para Peripheral Catheter Technical Name: Peripheral Intravenous Catheter ANVISA Registration Number: 80288090083 Hazard Class: II Affected Model: CIP01 - 24G - 0,7X19mm Lot / Serial Number Affected: 160386/103

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por TKL Importação e Exportação de Produtos Médicos e Hospitalares Ltda.; Disposafe Health and Lifecare Ltd..

¿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
    2249
  • Fecha
    2017-03-24
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    Immediately suspend the use of the product. Segregate the quantity into stock for recall.
  • Causa
    Received client notification on 03/21/2017 on the occurrence of a point deviation, identified in a single sample, where there was fragility in the catheter after puncture of the patient, which generated a rupture at the junction between the catheter and the cannula within the vein. the medical evaluation performed after x-ray examination did not identify the catheter and the patient was released. probable cause associated with the manufacturing process.
  • Acción
    Field Action Code 001/17 triggered under the responsibility of the company TKL Importation and Exportation of Medical and Hospital Products Ltda. Company will collect.

Device

Peripheral Catheter Technical Name: Peripheral Intravenous Catheter ANVISA Registration Number: 8...

Manufacturer

TKL Importação e Exportação de Produtos Médicos e Hospitalares Ltda.; Disposafe Health and Lifeca...
  • Source
    ANVSANVISA