The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning T-Piece Circuit, manufactured by Mercury Medical. Product affected was shipped after 18 January 2012. The affected part numbers and the corresponding lot numbers are:
T-Piece Neonatal Circuit Kit, Disposable
Neo-Tee Resuscitator
T-Piece Resuscitator Circuit
The T-Piece Circuit is a component used in conjunction with various T-Piece resuscitation devices. According to the safety alert, there is a potential that a silicone mask with a 15 mm male port is being able to be forcibly inserted into the protective cap covering the opening of the T-Piece Circuit. Incorrect use of the product in this way will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.
The manufacturer advises affected users to immediately notify all personnel subject to using these devices to remove the protective cap before connecting a mask. Besides, the manufacturer is in process to physically eliminate the potential for this erroneous use. The instructions for use are also being updated to warn users to remove the cap before use.
For details, please refer to the MHRA website:
https://www.gov.uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-28-september-to-2-october-2015
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 October 2015