Events

Field Safety Notices about Broviac Paediatric Catheter

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Becton, Dickinson and Company.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2003(01)
  • Date
    2003-02-13
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/broviac-paediatric-catheter&id=fc91f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Extra notes in the data
  • Reason
    The imb has been advised of several incidents with patients on long-term total parenteral nutrition using a broviac paediatric catheter.  defects developed at a similar point on the catheter, where the hub separated from the catheter.
  • Action
    The IMB advise that users of this product:  Ensure that all staff dealing with broviac lines are advised of the incidents that have arisen with this device.   Advise all staff and family members dealing with the device to carry out regular inspections of the device.   Ensure that all staff and family members are trained in the use of the catheter. Ensure the device is clamped at the points indicated by the manufacturer in their literature.   Report any indication of problems with the device to the Irish Medicines Board

Device

Broviac Paediatric Catheter

Manufacturer

Becton, Dickinson and Company