Events

Alerta De Seguridad para Entrada Needle (Accessory Infinion CX lead)

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

¿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
    2018-04-12
  • Fecha de publicación del evento
    2018-04-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180412b.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: entrada needle (accessory infinion cx lead) medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its entrada needle (accessory infinion cx lead). the affected devices are identified as the following: - product description: a) entrada 2.0 4.5” needle kit; b) entrada 2.0 6” needle kit; c) entrada 2.0 4.5” spare sheath kit; d) entrada 2.0 6” spare sheath kit universal product number: a) m365sc4220450; b) m365sc4220600; c) m365sc4220s450; d) m365sc4220s600 brand name: infinion cx lead approval number: 22700bzx00348000 the manufacturer has detected some products did not meet the acceptance criteria during a needle resistance loss leakage test in the accelerated 2 years aging test which was performed for an additional manufacturing site. therefore, the manufacturer is initiating voluntary removal of the products in japanese market. according to the manufacturer, if there is leakage of the products, the operator may not be able to feel sufficient resistance. this could potentially result in prolonged procedure and may puncture the spinal cord beyond the epidural space as severe health impact. however, as it is recommended that this procedure to be performed under x-ray fluoroscopy in the instruction, a severe health impact would not occur. while the product is currently being sold worldwide, there have been no complaints related to this event. the users are recommended to return unused removal products and not to use the affected products. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 april 2018.

Device

Entrada Needle (Accessory Infinion CX lead)
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: "Entrada Needle (Accessory Infinion CX lead)"
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH