Events

Retiro De Equipo (Recall) de SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por COVIDIEN.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    48488
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2012-07-19
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Certain size 8 shiley reusable cannula cuffed tracheostomy tubes have volume leakage and/or disconnection between the inner and outer cannulae.

Device

SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE
  • Modelo / Serial
    Model Catalog: LPC (Lot serial: from 110200327X to 120600351X); Model Catalog: FEN (Lot serial: from 110200327X to 120600351X); Model Catalog: LPC (Lot serial: from 0910000346 to 1101001823); Model Catalog: FEN (Lot serial: from 0910000346 to 1101001823); Model Catalog: LPC (Lot serial: from 110201893X to 120600700X); Model Catalog: FEN (Lot serial: from 110201893X to 120600700X); Model Catalog: LPC (Lot serial: from 0910000342 to 1101001558); Model Catalog: FEN (Lot serial: from 0910000342 to 1101001558)
  • Descripción del producto
    Shiley Low Pressure Cuffed Tracheostomy Tube 8 FEN /LPC
  • Manufacturer
    COVIDIEN

Manufacturer

COVIDIEN
  • Dirección del fabricante
    SAINT-LAURENT
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • 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
    HC