Rheovalves disposable needle-free valves: stop using specific lots due to risk of breakage in patient. DSI/2021/010
Baihe Medical have identified an increase in complaints for Rheovalves disposable needle-free valves product code RVNF1. Devices from specific lots are affected. There is a risk of the device breaking in use.
Devices details
Rheovalves disposable needle-free valves
Product code: RVNF1
Affected lot numbers: 0HH-T200316 & 0HH-T210710.
Manufactured by Guangdong Baihe Medical Technology (Baihe Medical) or branded as Linc Medical devices.
Summary
Baihe Medical have identified an increase in complaints for Rheovalves disposable needle-free valves product code RVNF1. Devices from specific lots are affected. There is a risk of the device breaking in use.
You should stop using the affected lots of devices whilst the manufacturer investigates and informs the MHRA of the outcome.
The manufacturer has previously issued a Field Safety Notice, but this is no longer valid as more information is now available.
Risk involved with using affected product
There is a risk of the product breaking whilst being removed from the access catheter, leading to the risk of infection for the patient.
Reported issues to date include:
- increased risk of infection – sepsis / bacteraemia
- delay in dialysis treatment
- fragments of connector remaining within the dialysis catheter
Actions for health care professionals – heads of renal units, renal nursing and IV nurse practitioners
- Identify whether you have any Rheovalve needle-free connectors of lot numbers 0HH-T200316 & 0HH-T210710, particularly in renal departments.
- Quarantine all unused stocks and contact your distributor or the manufacturer to confirm whether devices should be thrown away or returned.
- Identify patients who currently have the connectors used on their HD or other IV central lines. As clinically appropriate, undertake extra vigilance when removing the connector in line with established local protocols, as the device has the potential to break off in the catheter.
- Report any suspected or actual adverse incidents involving these devices through your healthcare institution’s local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.
- Sign up to receive email updates on alerts and device safety information from the MHRA.
Information for patients
No action is required by patients. This information is targeted at Healthcare Professionals who will identify if you are affected by this safety issue as part of your ongoing clinical care and take appropriate action at your next appointment.
Actions for manufacturers
The manufacturer Baihe Medical will provide a further update to the MHRA once they have completed their investigation