Alerta De Seguridad para VenaSeal Closure System Model SP-101

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

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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: medtronic venaseal closure system model sp-101 medical device manufacturer, medtronic, has issued a medical device safety alert concerning all former sapheon (covidien) venasea closure systems model sp-101. the manufacturer is conducting a voluntary recall of all former sapheon (covidien) venaseal closure systems due to potential for sterility breach of the outer packaging (pouch) material. a breach of the outer pouch may compromise the outside surface sterility of the sealed inner tray which does not directly affect the sterility of the device components. the manufacturer has received one complaint potentially related to this issue resulting in an occurrence rate of 0.0253%. this complaint is associated with a serious patient injury; however it is unclear if this injury is device related. there have been no reports of death related to this issue. according to the manufacturer, the breach in the pouch barrier may not be detectable by visual inspection of the product. while the device components within the sealed inner tray are not directly affected by this issue, the introduction of a non-sterile inner tray (outer surface of the inner tray contaminated) could potentially contaminate the sterile field and sterile personnel, thereby creating a possible indirect pathway for microbes to come in contact with the patient, which may cause an infection. if a patient has received treatment with a venaseal closure system, no action is required and patients should continue to be monitored in accordance with standard of care. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 may 2015.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic VenaSeal Closure System Model SP-101
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source