Use of Luer adaptors with Needle-Free Connection Systems and prefilled Syringes 에 대한 현장 안전성 서한

Field Safety Notice

SN2013(01)

2013-03-05

Ireland

HPRA

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

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.

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.