Events

Retiro De Equipo (Recall) de Device Recall Covidien Trellis 6 Peripheral Infusion System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States 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
    70048
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1017-2015
  • Fecha de inicio del evento
    2014-12-10
  • Fecha de publicación del evento
    2015-02-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132189
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter, continuous flush - Product Code KRA
  • Causa
    A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. units have been identified to have the distal balloon inflation port incorrectly labeled as proximal, and, the proximal balloon port incorrectly labeled as distal.
  • Acción
    Consignees were sent an Urgent Product Recall letter dated 12/15/2014. The letter described the issue, identified the affected product, and the required actions. Affected product was to be returned directly to customers' Covidien Sales Rep; or customers were to contact Covidien Service at 1-800-716-6700 to arrange for product return. Questions can be directed to the Covidien Sales Rep or to Covidien Service at 1-800-716-6700. Customers were to complete and return the Verification Form along with the unused product as soon as possible.

Device

Device Recall Covidien Trellis 6 Peripheral Infusion System
  • Modelo / Serial
    Model BVT608010, Lot numbers: 9853174, 9864497, 9890772, 9890931, 9925676, 9932672, 9937308, 9937315, 9940474, 9940614, 9976340, 9978233, A001589, A001740.   Model BVT608030, Lot Numbers: 9853331, 9887597, 9887695, 9887757, 9932042.   Model BVT612010, Lot numbers: 9854121, 9868214, 9868311, 9875472, 9875632, 9876174, 9883295, 9884788, 9884951, 9886196, 9886312, 9932096, 9968511, 9974109, 9974126, 9976472, 9977091, 9978862, A002299, A002423.   Model BVT312030, Lot numbers: 9854124, 9892081, 9941213, 9971096, 9971139, 9976506, 9977140, 9978964, 9979548, A003021, A003121, A003651, A007900, A008492, A008603, A008687.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Descripción del producto
    Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. || Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • Dirección del fabricante
    Covidien, 4600 Nathan Ln N, Plymouth MN 55442-2890
  • 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
    USFDA