The FDA is issuing an alert on Haiou safety needles as well as recommending healthcare providers stop using certain syringes and needles with needle safety devices manufactured by Guangdong Haiou Medical Apparatus Co., LTD. The FDA received information about quality issues, including certain Haiou needles detaching from the syringe and needle safety device failures.
- 1ml syringe with 25g x 1-inch needle
- 1ml syringe with 23g x 1-inch needle
Be aware that these syringes and needle configurations may be available as individual units or as part of a kit.
The FDA has reports where these needles have detached and remained in the patient’s arm. Incidents, where the needle safety function failed, has caused injuries to healthcare workers which increases the risk of bloodborne pathogens transmission. The FDA issued an import alert to prevent these syringe and needle configurations from entering the United States. The FDA is working to identify where these configurations have been distributed and inform those sites of quality issues.
The FDA is evaluating whether other HAIOU syringe and needle configurations may have similar problems. They encourage health care to report adverse events or suspected adverse events experienced with any syringe and needle configurations.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care personnel employed by facilities that are subject to these reporting requirements should follow their facilities reporting procedures.
To read the full alert: https://www.osha.gov/quicktakes/06012021
At TMC, our mission is to provide workplaces and organizations with the most up-to-date information on maintaining compliance with important governmental regulations.