Use of Luer adaptors with Needle-Free Connection Systems and prefilled Syringes

Notice type: Advisory

Date: 05/03/2013


Product name or type:
Use of Luer adaptors with Needle-Free Connection Systems and prefilled Syringes


Manufacturer Or Supplier:
Exempt Medicinal Products (current supply): Manufactured by Aurum Pharmaceuticals Ltd, UK and Supplied by Fannin Limited, Dublin 

Authorised Medicinal Products (future supply): Manufactured by International Medication Systems and supplied by UCB Pharma

Target Audience:
Hospital Managers / CEOs 
Risk Managers 
Clinical Directors 
Purchasing Managers 
Supplies Managers 
Nursing Managers 
Hospital personnel 
Private Medical Practitioners 
Hospital Pharmacists 
Resuscitation Officers 
Ambulance Services 

Please bring this safety notice to the attention of all who need to be aware of it.

Problem Or Issue:
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.

Background Information Or Related Documents:
Since November 2012, emergency medications such as adrenaline, atropine and amiodarone have been supplied to Irish hospitals in a new pre-filled syringe, which has replaced the Minijet presentation. Healthcare professionals have experienced some difficulty in preparing / administering these products to patients through certain needle-free connection systems. Reports have been received by the Irish Medicines Board (IMB) of blocked syringe bores, which made it impossible to administer a dose of potentially life-saving medication. 

The design of this new BD Hypak PRTC syringe renders it incompatible with some needle-free connection systems. 

The IMB is issuing this Safety Notice to ensure all users are aware of the issue.

Use of Luer adaptors with Needle-Free Connection Systems and prefilled Syringes Document

Actions To Be Taken:
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. 

Further Information:

Enquiries should be addressed to: 

Fannin Limited 
Marie Walsh 
Senior Regulatory Officer, Fannin Limited 
Telephone: 01-2907183 

UCB Pharma Ltd. 
208 Bath Road 
Berkshire SL1 3WEC 
Telephone: Med Info 0044-1753-534655 
Adverse Events 0044-1753-447690 


All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 

Please click here to view a PDF version of this Safety Notice

Please click here to view the instructions poster

Please click here to view the Martindale Compatibility Statement

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