Events

Alerta De Seguridad para ProTrack Microcatheter

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Baylis Medical.

¿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
  • Fecha
    2015-11-03
  • Fecha de publicación del evento
    2015-11-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151103a.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: baylis medical protrack microcatheter medical device manufacturer, baylis medical, has issued a medical device safety alert concerning its protrack microcatheter. the affected part and lot numbers are as follows: part number (lot number): cic35-145 (cifa131113, cifa100614, cif8100714, c1fa241014) part number (lot number): cic38-145 (cifa161013, cifa271113, cifa311213, cifa210214, cifa070314, cifa270314, cifa070514, cifa210514, cifa240614, cifa100714, cifa180814, cifa080914, cifa221014, cifa050115, cifa210115 and cifa060215). the manufacturer is voluntarily recalling 20 lots of protrack microcatheter (cic35-145, clc38-145) due to the possibility that the catheter may have circumferential cracks along its length. the cracks may result in leakage of fluids along the catheter. according to the manufacturer, there have been no adverse event reports related to this discovery. affected users are advised to immediately segregate all affected product and ensure that it will not be used. product replacement is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 november 2015.

Device

ProTrack Microcatheter
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baylis Medical ProTrack Microcatheter
  • Manufacturer
    Baylis Medical

Manufacturer

Baylis Medical