U.S. Food and Drug Administration Center for Devices and Radiological Health He warned that plastic syringes made in China distributed in the U.S. have “more widespread” quality control problems than previously thought.
IN safety communication On Tuesday, the FDA found that three Chinese syringe manufacturers had violated its regulations.
CNBC has been investigating this case since November The FDA initially announced reviewed reports of quality and performance issues with these syringes, including leaks and cracks. After CNBC asked concerning the matter for months, the agency published the announcement updated Safety Communications and its Center for Devices and Radiological Health released a release saying the continuing review “confirmed that problems with the quality of plastic syringes manufactured in China and their distribution in the U.S. are more common than initially thought.”
In its safety announcement, the FDA said it sent warning letters to 3 Chinese manufacturers on Monday: Jiangsu Shenli Medical Production Co. Ltd.Chinese manufacturer of plastic syringes, as well Medline Industries LP AND Sol-Millennium Medical Inc.two corporations marketing and distributing plastic syringes made in China in the US. The letters cited violations related to the sale and distribution of unauthorized plastic syringes made in China which have not been approved by the FDA to be used in the U.S.
In a January statement to CNBC, the agency wrote that it had received more than 4,000 reports of problems with plastic syringes in 2023, adding that the number was not limited to syringes manufactured in China. The agency further wrote that there are “limitations” to this data, corresponding to “incomplete reporting information” and “potential underreporting.”
As a part of a months-long investigation, CNBC reviewed a whole lot of medical device report reports, or MDRs, which are reports to the FDA intended to spotlight suspected problems or failures with medical products.
In reports reviewed by CNBC, which checked out manufacturers beyond those who have recently issued warnings, some customers and doctors say they found: “foreign matter” in syringes. Others claimed that “many needles break off in vials when preparing vaccines”, “bow delivers faster than it should” and that the syringes “broken“, among others. In one medical device report in the case of Jiangsu Shenli Medical Production, which was one of the manufacturers that received the warning letter, a customer reported that the syringe caused “inaccurate measurement of the vaccine.”
IN statement released Thursday concerning the FDA’s safety announcement and warning, Sol-Millennium Medical wrote that it was “confident” it could address the agency’s concerns. She added that since September 2023, the FDA has inspected about one-third of the company’s shipments to the U.S. and has “zero quality concerns.”
The other two companies that issued warning letters did not respond to CNBC’s request for comment.
According to FDA reports on medical devices DatabaseJiangsu Shenli Medical Production and Sol-Millennium Medical produce plastic syringes for , a significant pharmaceutical manufacturer based in Irving, Texas.
In your notice The FDA wrote that U.S. suppliers, consumers and health care organizations should “immediately discontinue” the use of plastic syringes manufactured by Jiangsu Caina Medical Co. Ltd. and unauthorized plastic syringes manufactured by Jiangsu Shenli Medical Production unless “absolutely mandatory”. For all remaining plastic syringes produced in China, the agency said they should be used as needed until a switch can be made, and urged users to monitor them for defects.
McKesson did not immediately respond to a request for comment.
According to FDA data, in addition to Jiangsu Shenli Medical Production and Sol-Millennium Medical, there are other Chinese manufacturers producing plastic syringes for McKesson. Medical device reports also include a link Anhui Tiankang Medical Technology Co. Ltd., Jiangsu Medicine in China, Suzhou Linhwa Medical Devices Co. Ltd. AND Shanghai Kindly Enterprise Development Group Co. to McKesson.
McKesson is not the only pharmaceutical giant having problems with its syringes. Cardinal’s health AND Fresenius medical care over the past few months, they have also experienced first-degree withdrawal – the most serious type of withdrawal – of syringes. According to the recall, resizing of Cardinal Health Monoject syringes when used with different pumps caused problems such as incorrect dosing, therapy delays, and pump malfunctions, including occlusion alarms and feeding delays. IN press release as of February, Cardinal Health said its goal was to provide “protected, high-quality products” and had not received any reports of patient deaths from these syringes, but added that “there may be a possible risk of significant 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 material inside the syringe. In November press releaseFresenius said it has sent recall notices to 1,699 customers in connection with the voluntary recall of its syringe products from the market.
In its statement to CNBC, the FDA said it believes supply and production capability for plastic syringes made in countries other than China, including the U.S., is sufficient to forestall shortages. The agency also said it could proceed to judge problems with syringes made in China.
