The U.S. Food and Drug Administration (FDA) on May 20 advised medical personnel to suspend the use of two models of needles and syringes with needle safety devices manufactured by China’s Guangdong Hai-O Medical Devices Co.
Reuters reported today (May 21) that U.S. authorities have received multiple reports of medical devices and other complaints about the quality of 1mL syringe with a 25Gx1-inch needle and 1mL syringe with a 23Gx1-inch needle manufactured by Hai-O Medical Devices Co.
These problems include the needle dislodging from the needle syringe configuration and remaining on the patient’s arm after injection; or the needle safety feature failing (e.g., failing to activate or not retracting); and a small number involving accidental needlestick injuries to medical personnel.
FDA warns that the risks associated with the above issues may include pain, infection, and surgery (if the needle breaks off in a person’s arm). Medical personnel are also at risk of bloodborne pathogen transmission involving accidental needlestick injuries.
At this time, the FDA has not identified a situation that would require surgical removal of the needle.
An FDA spokesperson said the devices have been discontinued from shipment as a New Coronavirus (COVID-19, CCLV) vaccination tool since March 22. The agency does not believe that discontinuing the use of these syringes will cause delays in the vaccination program.
Erin Fox, senior director of drug information at the University of Utah Medical Center, said the syringes were previously received from Seagull Medical at the same time as the Pfizer vaccine, and were part of the kit of ancillary supplies that came with McKesson.
On April 30 of this year, the FDA has issued an import warning for the two syringes to prevent them from entering the U.S. It is also evaluating other syringes and needles from Seagull Medical for similar problems.
The FDA is advising healthcare facility risk managers, procurement staff and medical personnel to stop using these two needle syringes until further notice.
According to the official website of Guangdong Hai-O Medical Devices Co., Ltd, the company was founded in 1997 and specializes in the research and development, production, sales and service of sterile medical devices.
Previously, a variety of medical supplies produced in China were exposed to quality problems, such as this April when the Canadian media disclosed that many Chinese-made KN95 masks on the Canadian market were substandard, some of which could only filter about 20% of suspended particles, far below the 95% standard. In April last year, the European Union also notified four Chinese masks as “serious” (Serious) warning products, testing found that the actual filtration capacity is insufficient, the worst filtration efficiency is even below 50%.
The BBC reported last June that Celso Granato, clinical director of the FLEURY laboratory in São Paulo, said in an interview that in February or March 2020, a large number of Chinese quick-screening kits arrived in Brazil and “we tested 11 different brands of quick-screening reagents and 9 out of 11 were complete junk “
The UK has disclosed that the Shangrila 510 ventilator, made by Beijing Yi’an, could cause great harm, including death, to patients.
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