FDA: Chinese firm’s syringes have needle issues

• The FDA has warned against using certain syringes and needles manufactured by Chinese firm Guangdong Haiou Medical Apparatus Co after several incidents with the needles.
• Reports of quality issues included incidents of needles detaching from the syringe and getting stuck on the patient or healthcare provider.
• The FDA has issued an import alert and assured that stopping usage of the syringes will not delay vaccinations.

Quality issues involving syringes and needles manufactured by Chinese medical device maker Guangdong Haiou Medical Apparatus Co (HAIOU) have prompted the U.S. Food and Drug Administration (FDA) to ask healthcare providers on Thursday to stop using the devices.

Erin Fox, senior director of drug information at the University of Utah Health, said that the syringes had previously been shipped for use with the Pfizer Inc /BioNTech SE COVID-19 vaccine as part of the ancillary supply kits shipped by McKesson Corp. She added that they have been using the syringes in March, but have not since used them for a while and are no longer currently using them.

The devices have been stopped from being shipped with COVID-19 vaccination kits as of March 22, an FDA spokesperson stated.

The agency assured that stopping the usage of these syringes will not lead to delays in vaccination schedules.

Among the reports of quality issues received by the FDA include certain HAIOU needles detaching from the syringe. Some needles got stuck to the patient’s arm after injection while some healthcare providers reported accidental needlestick injuries.

The FDA has since asked healthcare providers to stop using two of HAIOU’s syringe-needle combinations — the 1mL syringe with 23G x 1-inch needle and 1mL syringe with 25Gx 1-inch needle — until further notice.

An import alert has been issued by the agency on April 30. This prevents the said syringe and needle configurations from entering the United States.

Source: Reuters