The U.S. Food and Drug Administration’s Center for Devices and Radiological Health has warned that Chinese-made plastic syringes which are distributed within the U.S. have “more widespread” quality control issues than were previously known.
In a safety communication Tuesday, the FDA said it found three Chinese syringe manufacturers were in violation of its regulations.
CNBC has been investigating the difficulty since November, when the FDA initially announced it was reviewing reports of quality and performance issues with these syringes, including leaks and breakage. After CNBC had been inquiring in regards to the issue for months, the agency released an updated safety communication and its Center for Devices and Radiological Health published a release stating its ongoing evaluation “has confirmed that issues with the standard of plastic syringes made in China and their distribution within the U.S. are more widespread than originally known.”
In its safety communication, the FDA said that on Monday, it sent warning letters to a few Chinese manufacturers: Jiangsu Shenli Medical Production Co. Ltd., a China-based manufacturer of plastic syringes, in addition to Medline Industries LP and Sol-Millennium Medical Inc., two firms marketing and distributing plastic syringes made in China inside the U.S. The letters cite violations related to the sale and distribution of unauthorized plastic syringes made in China that aren’t cleared by the FDA to be used within the U.S.
In a January statement to CNBC, the agency wrote that in 2023, it received greater than 4,000 reports regarding plastic syringe issues, adding that this figure was not limited to simply syringes manufactured in China. The agency further wrote that there have been “limitations” to this data, equivalent to “incomplete information within the reports” and “potential under-reporting.”
As a part of its monthslong investigation, CNBC reviewed tons of of narratives for syringe medical device reports, or MDRs, that are submissions to the FDA designed to focus on suspected issues or malfunctions related to medical products.
Within the reports CNBC reviewed, which checked out manufacturers beyond those issued the recent warning letters, some customers and physicians say they found “foreign matter” in syringes. Others said they’d “multiple needles break off within the vials when drawing up vaccines,” “medication delivering faster than it should,” and that the syringes were “cracked,” amongst other issues. In a single medical device report for Jiangsu Shenli Medical Production, which was one among the manufacturers given a warning letter, a customer reported the syringe was causing “an inaccurate measurement of vaccine.”
The three firms issued warning letters didn’t immediately reply to CNBC’s request for comment.
In accordance with the FDA’s medical device reporting database, Jiangsu Shenli Medical Production and Sol-Millennium Medical produce plastic syringes for McKesson, a serious pharmaceutical manufacturer headquartered in Irving, Texas.
In its notice, the FDA wrote that U.S. suppliers, consumers and health-care organizations should “immediately transition away” from using plastic syringes manufactured by Jiangsu Caina Medical Co. Ltd. and unauthorized plastic syringes manufactured by Jiangsu Shenli Medical Production unless “absolutely needed.” In regard to all other plastic syringes manufactured in China, the agency said that they ought to be used as needed until a transition to a different product is feasible, and urged that users should monitor for defects.
McKesson didn’t immediately reply to a request for comment.
Along with Jiangsu Shenli Medical Production and Sol-Millennium Medical, there are other China-based manufacturers that produce plastic syringes for McKesson, based on FDA data. Medical device reports also link Anhui Tiankang Medical Technology Co. Ltd., Jiangsu Caina Medical, Suzhou Linhwa Medical Devices Co. Ltd. and Shanghai Kindly Enterprise Development Group Co. to McKesson.
McKesson is not the only pharmaceutical giant facing issues with its syringes. Cardinal Health and Fresenius Medical Care have also had class one recalls — essentially the most serious sort of recall — for his or her syringes previously several months. In accordance with the recall, the dimensions changes in Cardinal Health Monoject syringes when used with various pumps caused problems equivalent to incorrect dosages, therapy delays and pump malfunctions, including occlusion alarms and feeding delays. In a press release from February, Cardinal Health said its goal is to offer “secure, high-quality products” and it has not received received any reports of patient death attributable to these syringes, but added “there’s a possible risk of great injury or death.”
The FDA said Fresenius recalled its product attributable to reports of syringe leakage in addition to reports of unknown black material contained in the syringe. In a November press release, Fresenius said it sent recall notifications to 1,699 customers about its voluntary removal of its syringe products from the market.
In its statement to CNBC, the FDA said it believes the provision and manufacturing capability of plastic syringes made in countries aside from China, including within the U.S., is sufficient to produce a shortage. The agency also said it is going to proceed to guage problems with syringes made in China.