Washington — The U.S. Food and Drug Administration sent warning letters to medical suppliers amid its evaluations of quality and performance issues in plastic syringes made in China.
FDA announced in November 2023 that it was monitoring reports of safety issues associated with "several Chinese manufacturers of syringes."
It is also "taking steps to refuse entry of these devices into the United States" until violations are addressed by the companies, it said in a March 11 letter to Jiangsu Shenli Medical Production Co. Ltd.
FDA found the company based in Changzhou marketed plastic piston syringes in the U.S. without marketing clearance or approval, violating the Federal Food, Drug and Cosmetic Act.
"We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance, and our evaluation is ongoing," FDA's statement added.
The syringe devices violate the law "because your firm does not have an approved application for premarket approval in effect … or an approved application for an investigational device exemption," it said. "The devices are also misbranded. … Because your firm introduced or delivered for introduction into interstate commerce for commercial distribution, these devices with major changes or modifications to the intended use and/or a change or modification in the device … could significantly affect the safety or effectiveness of the device without submitting a premarket notification to FDA."
FDA requested the Jiangsu Shenli Medical production factory to "cease any activities that result in the misbranding or adulteration of all the Jiangsu Shenli Medical Production Co. Ltd. piston syringe configurations … including selling to initial importers, distributors or other third parties for distribution and use within the U.S., or otherwise representing these devices to have the requisite clearance or authorization for marketing in the U.S."
"Given the serious nature of the violations of … and growing evidence of potential harm, all the Jiangsu Shenli Medical Production Co.,Ltd. piston syringes … are subject to refusal of admission … in that they appear to be adulterated," it said.
FDA also sent a letter to distributor Medline Industries LP, a customer of Jiangsu Shenli, and Jiangsu Caina Medical Co. Ltd., for its "failure to ensure the syringes" it included in its "convenience kits" have clearance from the FDA.
"FDA has observed evidence of post-market safety signals indicating product quality issues that have the potential to cause serious patient harm," the March 18 letter said. "Our inspection revealed multiple customer complaints regarding quality issues — e.g. cracks, breakage during use — for syringes in your surgical kits that include syringes supplied by Jiangsu Shenli Medical Production Co., Ltd that you failed to properly investigate."
"The FDA expects these entities to fully address the violations described in the warning letters," it said in a March 19 statement. "In addition, we are actively evaluating quality issues and performance testing failures with plastic syringes made by Jiangsu Caina Medical Co., Ltd., a China-based manufacturer, cited in the warning letter issued to Medline Industries LP."
Performance testing of Jiangsu Caina plastic syringes also "showed unexpected and unexplained failures," the statement said.
In another March 18 letter, to distributor Sol-Millennium Medical Inc., FDA said "several" of the company's product lines "were not included" under a previous clearance condition established with FDA.
"Your firm's promotion of the InviroStripe standard luer lock syringes provides evidence that you are marketing syringes with substantially different technological characteristics, namely ... syringes with blunt fill needles, luer lock syringes with pre-staked safety needles, luer lock syringes with exchangeable hypodermic needles, luer slip syringes and eccentric tip syringes," the letter said.
"Each of these different technological characteristics constitutes a significant change or modification in design that could significantly alter the safety and effectiveness of the InviroStripe standard luer lock syringe without submitting a [notice] to FDA," it said. "Specifically, switching from a luer lock to a luer slip or eccentric syringe tip, and including a new component such as a needle, could result in the risk of patient harm such as inaccurate dosing, a leaking device, contamination and a higher risk of inappropriate needle detachment."
It "could also lead to adverse health effects such as allergic reactions, skin irritation or inflammation, pain, fever, red blood cell damage that induces organ stress, and toxicity that leads to loss of organ function or failure," the letter added.
"The FDA will continue to work with stakeholders, including other federal agencies, medical device manufacturers and health care organizations, to ensure the safety of syringes being used in the U.S.," Kristina Wieghmink, communications officer for the Center for Devices and Radiological Health at FDA, told Plastics News in an email.
"We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance, and our evaluation is ongoing," the FDA's statement added.
FDA recommends U.S. suppliers of plastic syringes, consumers, health care providers and facilities "immediately transition away from using plastic syringes manufactured by Jiangsu Caina … unless use of these syringes is absolutely necessary," and immediately transition away from using unauthorized plastic syringes manufactured by Jiangsu Shenli … [including] all models other than the 5 mL Luer-Lock syringe, unless … absolutely necessary."