Concerns Raised Regarding Safety And Performance Of Devices

Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert in relation to a 1ml safety syringe 27G device manufactured by Medicina.

Concerns have been raised that the devices with the product code RN01/27i are unable to deliver less than seven units of insulin, while the safety and performance of the items is thought not to have been properly evaluated.

The MHRA has urged healthcare workers to not use the affected devices, quarantine them and arrange for their collection.

Among those who have been informed of the medical device alert directly are NHS boards and trusts across the UK, as well as the Care Quality Commission, clinical commissioning groups and special health authorities.

If you or a loved one has suffered due to a defective medical device or medicine, our medical negligence solicitors could help you claim compensation. View our Defective Medical Products Drugs Or Medicines Claims page for more information.

Expert Opinion

Considering the seriousness of the concerns raised regarding this safety syringe, it is very welcome to see the MHRA issuing this warning in order to prevent patients from facing any potential harm. <br/> <br/>"Sadly, our work means we have numerous cases in which people have suffered illness or injury as a result of the use of faulty and defective products during care and treatment. <br/> <br/>"We have long-held concerns regarding the number of medical device alerts issued in recent months, which each instance highlighting where faulty products have made it to market despite the regulatory processes which are in place to prevent this. <br/> <br/>"This clearly raises concerns regarding the framework and it is vital that steps are taken to understand how faults of this nature emerge, with the ultimate aim of ensuring that the same issues are not seen again." Kevin Timms - Solicitor