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Neria Steel Cannula Infusion sets manufactured by Unomedical

Notice type: Advisory

Date: 21/08/2012

   

Product name or type:
Neria Steel Cannula Infusion sets manufactured by Unomedical

Reference:
SN2012(12)

Manufacturer Or Supplier:
Unomedical a/s

Target Audience:
Hospital 
Hospital CEOs 
Hospital Risk Managers 
Medical Nursing Staff 
Paramedics 
Palliative Care Units 
Intensive Care Units 
Haematologists 
Haematology nurse specialist 
Anaesthetic Officers 
General Practitioners 
Practice Nurses 
Clinical Engineers 
Hospices 
Nursing Homes 
Community Care Managers 
Community Therapists 
Carers 
Pharmacists 

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

Problem Or Issue:
There is a risk that the needle of the neria steel cannula infusion set may break during use leading to leakage of medication and the potential need for surgical intervention to remove the needle.

Background Information Or Related Documents:
Unomedical has found that in rare cases the steel needle can break during use. This can lead to leakage of medication and the needle may require surgical removal. Through their investigation, the manufacturer has confirmed that this issue may occur on certain device models for sets with expiry dates up to and including January 2017. The expiration date is shown on the packaging as yyyy-mm. 

The manufacturer has distributed the attached Field Safety Notice (FSN) to its customers providing information to identify potentially affected devices and to provide advice for using the infusion sets safely. 

Unomedical has informed the Irish Medicines Board (IMB) that all users that were supplied with the affected devices may not have received a copy of the FSN. The IMB is issuing this Safety Notice to ensure all users of the potentially affected devices are aware of the issue. 

Neria Steel Cannula Infusion sets manufactured by Unomedical Document

Actions To Be Taken:
1. Ensure that the relevant personnel in your organisation are made aware of this issue. 

2. Determine whether you have purchased a device that could be affected by this issue by reviewing the attached FSN. 

3. Ensure that all users of these devices are aware of the information supplied by the manufacturer in the attached FSN to ensure safe use of the devices. 

Further Information:
Enquiries to the manufacturer should be addressed to: 

Cindie Vandfeldt 
Unomedical a/s 
Infusion Devices 
Aaholmvej 1-3, Osted 
DK - 4320 Lejre 
Denmark 
Email: Buid.complaints@convatec.com 

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 
E-mail: devicesafety@hpra.ie
Website: www.hpra.ie 

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

Please click here to view the Field Safety Notice

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