Events

Field Safety Notices about Use of Luer adaptors with Needle-Free Connection Systems and prefilled Syringes

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Aurum Pharmaceuticals Ltd.

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
    SN2013(01)
  • Date
    2013-03-05
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/use-of-luer-adaptors-with-needle-free-connection-systems-and-prefilled-syringes&id=707cf825-9782-6eee-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
    Emergency medicinal products supplied in bd hypak pre-filled syringes are not compatible with certain needle-free connection systems, without the use of an adaptor.
  • Action
    1. MicroCLAVE Connection Systems  When using BD Hypak PRTC Syringes with MicroCLAVE Connection Systems, 011 CS-25 Adaptors, manufactured by ICU Medical, should be used. Failure to use an adaptor can cause the connector tip to break and lodge in the syringe tip.  Every delivery by Fannin of these pre-filled syringes is accompanied by the required number of 011 CS-25 Adaptors. These adaptors are CE marked medical devices.  Extra adaptors are available from Fannin at the contact details below, as are instruction posters for distribution within your hospital. Please find a copy of the instructions poster attached. 2. Vygon Bionector 2 Connection System  When using BD Hypak PRTC Syringes with the Vygon Bionector 2 Connection System, Vygon ATP431 Adaptors should be used. Vygon supplies these adaptors on request. These adaptors are CE marked medical devices.  3. Other Connection Systems  There may also be other brands or products on the market which come in the Hypak PRTC syringe. Whichever needle-free system is being used, it is of critical importance to ensure that the necessary measures are in place, to allow safe and quick administration of these important medications. Information is available on the Martindale website, which confirms compatibility of the Hypak PRTC Prefilled Syringe with needle-free connection systems.  Please find a copy of the Martindale Compatibility Statement attached.

Device

Use of Luer adaptors with Needle-Free Connection Systems and prefilled Syringes
  • Model / Serial
  • Product Description
    Use of Luer adaptors with Needle-Free Connection Systems and prefilled Syringes
  • Manufacturer
    Aurum Pharmaceuticals Ltd

Manufacturer

Aurum Pharmaceuticals Ltd
  • Source
    HPRA