Events

Retiro De Equipo (Recall) de Device Recall Bard(R) Premature Infant Feeding Tube

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 C.R. Bard, Inc..

¿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
    79507
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1354-2018
  • Fecha de inicio del evento
    2018-02-27
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162513
  • 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
    Tube, feeding - Product Code FPD
  • Causa
    Bmd has identified that the product code/lot number combination identified above may have ineffectively fused tubing and enfit(tm) connector.
  • Acción
    The firm initiate their recall by letter on 02/27/2018 by letter. The recall letter stated: "Action required: " Immediately examine your inventory and quarantine product subject to this recall. Please refer to the sample product labeling on Attachment 1 to help you locate the product. Do not use or further distribute any affected product. " Please complete and return the accompanying Recall & Effectiveness Check Form attached to this letter regardless of whether or not you have any of the affected product. Additional instructions for product return are contained on the form. Upon receipt of the form indicating there is product to return, the BMD Recall Coordinator will issue you a return authorization number for return of the affected product. " If you have further distributed any units from the affected lots, please identify your customers and notify them at once of this product recall by forwarding a copy of this letter. Your notification should include a copy of this letter and the accompanying enclosures. This recall should be carried out to the user level."

Device

Device Recall Bard(R) Premature Infant Feeding Tube
  • Modelo / Serial
    Lot Numbers: NGAXX216, NGAVX224, NGBN2861
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 || Product Usage: || BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-eyed tube used for nasogastric feeding of neonates, infants and adults as well as diagnostic and therapeutic aspiration. These products are sold single-use, sterile. The Feeding Tube with the ENFit(TM) connector provides a way to reduce the risk of enteral device misconnections. The ENFit(TM) connector: Addresses patient side connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other enteral devices. Does not allow connectivity with any other connector for any other clinical use.
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.
  • Dirección del fabricante
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA