Events

Alerta De Seguridad para BioPath 035

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

¿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
    2015-02-23
  • Fecha de publicación del evento
    2015-02-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150223d.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: biosensors international biopath 035 medical device manufacturer, biosensors international, has issued a field safety notice concerning biopath 035, with the following details: model bpth-35-60100l (balloon diameter 6.0 x 100mm length – catheter length 135cm) all lot numbers for this model manufactured prior to november 2014 are affected. the manufacturer has received a report regarding a compatibility issue with the recommended sheath introducer size. the product is currently labelled for a 5f sheath introducer compatibility when the product specification is indicating a 6f recommendation. according to the manufacturer, this mislabeling has no impact on patient safety but it may lead to a prolonged procedure. patients who have already been successfully treated with an affected device are not impacted by this action. the manufacturer advises users to identify and quarantine the affected products. they will contact the affected users to arrange the corrective action. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 february 2015.

Device

BioPath 035
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Biosensors International BioPath 035
  • Manufacturer
    Biosensors International

Manufacturer

Biosensors International