BD intensifies syringe output to meet U.S. demand amid China quality concerns

BD’s North Canaan plant has increased its output of syringes by more than 40% to meet the needs of U.S. healthcare customers after the FDA launched an ongoing investigation into quality issues with plastic syringes made in China.

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BD intensifies syringe output to meet U.S. demand amid China quality concerns

NORTH CANAAN — Becton, Dickinson and Company (BD) has ramped up its production of syringes at its North Canaan plant in response to quality issues with plastic syringes imported from China which were uncovered late last year by the U.S. Food and Drug Administration (FDA).

BD, a leading global medical technology company and Northwest Connecticut’s largest employer, responded to the FDA’s recommendation that consumers, healthcare providers and healthcare facilities transition away from plastic syringes made in China by increasing its domestic manufacturing of syringes at the company’s Connecticut and Nebraska facilities.

Since January, BD’s 385,000-square-foot North Canaan plant has increased its output of syringes “by over 40% to meet the needs of U.S. healthcare customers,” according to Fallon McLoughlin, director of public relations and corporate communications for the Franklin Lakes, N.J.-based company.

“BD has achieved this increase by driving operational efficiencies and relocating some production lines from other BD plants,” said McLoughin.

“We’ve added over 100 full-time associates in the last year, and currently have more than 500 full-time associates and nearly 50 contingent associates,” she said of the North Canaan site, which began its operations in 1961 with eight employees at a 25,000-square-foot facility.

BD draws its employees from throughout Northwest Connecticut and neighboring New York.

McLaughlin noted that its Connecticut plant primarily manufactures small-size syringes, and syringe and needle combination products that are “critical to the delivery of healthcare.”

Operations take place around the clock, producing more than 2 billion medical devices each year that are sold in every region worldwide.

Responding to consumer needs

In March, Eric Borin, president of BD Medication Delivery Solutions, announced a statement saying: “BD has the capacity to support additional syringe demand and is further increasing U.S. production to help ensure continuity of patient care.”

Since the initial FDA safety communication in November 2023, he noted, “BD has increased domestic manufacturing of syringes in our Nebraska and Connecticut facilities to respond to customer needs. Ensuring the safety and quality of our products is the top priority at BD.”

Borin further noted at the time that “The latest FDA safety communication does not include any BD syringes. Over our more than 125-year history, we have served the health care system’s need for essential high quality medical products, including manufacturing 2 billion additional syringes and needles to support the global pandemic response to COVID-19.”

Syringe manufacturers in China cited

In late November 2023, the FDA announced its probe into reports of leaks, breakages and other quality problems with plastic syringes manufactured in China “that are used for injecting fluids into or withdrawing fluids from, the body,” according to the health regulator.

On March 14, the FDA issued an update on warning letters sent to three entities: Jiangsu Shenli Medical Production Co. Ltd, Medline Industries, LP and Sol-Millennium Medical Inc., describing violations related to the “sale and distribution of unauthorized plastic syringes that had not been cleared or approved by the FDA,” according to a new release.

“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 sited in the warning letter issued to Medline Industries, LP. The FDA will take additional steps as appropriate,” the FDA stated.

In its August 16 update, the FDA continued to recommend that healthcare providers “use syringes not manufactured in China, if possible.

“At this time, glass syringes, pre-filled syringes or syringes used for topical purposes are not included. If you only have syringes manufactured in China, then continue to use them as needed until you are able to use alternative syringes and closely monitor for leaks, breakage and other problems,” the FDA announced.

In March, BD was named to Fortune’s 2024 list of America’s Most Innovative Companies, and in September, the company announced that it had been named to TIME’s 2024 list of the World’s Best Companies based on employee feedback.

BD’s operations in North Canaan have also been recognized by the U.S. Environmental Protection Agency for achieving the Energy Star Challenge for Industry for energy reduction. The site is a landfill-free site where waste is reduced, recycled or converted into energy.

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