Events

Retiro De Equipo (Recall) de Arrow 4Fr Single Lumen Pressure Injectable Peripherally Inserted Central Catheter (PICC)

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Arrow International 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
    19162
  • Fecha de inicio del evento
    2015-10-13
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Causa
    There is a labelling inaccuracy in the instructions for use (ifu) and injection card. the ifu and the injection card contained within the product states that picc testing included 10 pressure injection cycles. this is not correct, it should state that catheter testing included 5 pressure injection cycles., if it were to be used for more than five (5) pressure injections, it cannot be ruled out that there is a potential risk that the catheter could rupture during injections 6-10. catheter rupture can cause catheter or air embolism, bleeding or ineffective treatment and may require the need for radiologic or surgical intervention. no customer complaints have been received for this issue.
  • Acción
    Instructions for use to be updated

Device

Arrow 4Fr Single Lumen Pressure Injectable Peripherally Inserted Central Catheter (PICC)

Manufacturer

Arrow International Inc