The US Food and Drug Administration's Center for Devices and Radiological Health has warned that Chinese-made plastic syringes distributed in the United States have “more widespread” quality control problems than previously known.
In a safety letter on Tuesday, the US Food and Drug Administration said it had found that three Chinese manufacturers of the injection had violated its regulations.
CNBC has been investigating this issue since November, when the FDA initially announced it was reviewing reports of quality and performance issues related to these syringes, including leaks and breakages. After CNBC inquired about the issue for several months, the agency issued an updated safety statement and its Center for Devices and Radiological Health published a statement explaining that its ongoing assessment “confirmed that issues with the quality of plastic syringes made in China and distributed in the United States are more widespread than originally known.”
In its safety letter, the FDA said it sent warning letters on Monday to three Chinese companies: Jiangsu Xinli Medical Production Co., Ltd., a China-based plastic syringe manufacturer, as well as Medline Industries LP and Sol-Millennium Medical. Inc., two companies that market and distribute plastic syringes made in China within the United States. The letters cite violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been licensed by the Food and Drug Administration for use in the United States.
In a January statement to CNBC, the agency wrote that in 2023, it received more than 4,000 reports regarding problems with plastic syringes, adding that this number was not limited to syringes manufactured in China. The agency also wrote that there are “limitations” to this data, such as “incomplete information in reports” and “possible underreporting.”
As part of its months-long investigation, CNBC reviewed hundreds of accounts of injectable medical device reports, or MDRs, which are reports to the FDA designed to highlight suspected problems or malfunctions associated with medical products.
In reports reviewed by CNBC, which looked at manufacturers other than the ones that issued the most recent warning letters, some customers and doctors say they found a “foreign substance” in the syringes. Others said that “several needles broke off in vials when preparing vaccines,” “medicines arrived too quickly,” and that syringes “cracked,” among other things. In one medical device report for Jiangsu Shenli Medical Production, which was one of the manufacturers to receive a warning letter, a customer reported that the syringe was causing “inaccurate vaccine measurement.”
The three companies issued warning letters and did not immediately respond to CNBC's request for comment.
According to the US Food and Drug Administration's Medical Device Reporting Database, Jiangsu Shenli Medical Production Company and Sol-Millennium Medical Company produce plastic syringes Maxona major pharmaceutical manufacturer headquartered in Irving, Texas.
U.S. suppliers, consumers and health care organizations should “immediately move away” from using plastic syringes made by Jiangsu Caina Medical Co., the FDA wrote in its notice. Ltd. and unauthorized plastic syringes made by Jiangsu Shenli Medical Production unless they are “absolutely necessary.” Regarding all other plastic syringes manufactured in China, the agency said they should be used as needed until the transition to another product is possible, and it urged users to monitor defects.
McKesson did not immediately respond to a request for comment.
In addition to Jiangsu Shenli Medical Production and Sol-Millennium Medical, there are other China-based manufacturers that produce plastic syringes for McKesson, according to FDA data. Medical device reports also link Anhui Tiankang Medical Technology Co., Ltd. Ltd. Jiangsu Caina Medical and Suzhou Linhwa Medical Devices Co., Ltd. Ltd. And Shanghai Kindly Enterprise Development Group Co., Ltd. McKesson Company.
McKesson isn't the only pharmaceutical giant facing problems with its syringes. Cardinal Health and Fresenius Medical Care also had Tier 1 recalls — the most serious type of recall — of their injectables in the past few months. According to the recall, volume changes in Cardinal Health Monoject syringes when used with different pumps caused problems such as incorrect dosing, treatment delays and pump malfunctions, including clog alarms and feeding delays. In a February press release, Cardinal Health said its goal is to provide “safe, high-quality products” and had received no reports of a patient dying from these syringes, but added “there is a potential risk of serious injury.” Or death.”
The FDA said Fresenius recalled its product due to reports of a syringe leaking as well as reports of an unknown black substance inside the syringe. In a November press release, Fresenius said it had sent recall notices to 1,699 customers regarding the voluntary removal of its injection products from the market.
In its statement to CNBC, the FDA said it believes the ability to supply and manufacture plastic syringes made in countries other than China, including the United States, is sufficient to prevent shortages. The agency also said it would continue to evaluate issues with syringes made in China.
