FDA Probe On China-Made Syringes: Becton Dickinson Boosts US Syringe Output Following Concerns

Thursday, Becton Dickinson And Co BDX said it increased production of medical syringes in the U.S. after the FDA recommended not using some China-made syringes as part of its ongoing quality probe.

Eric Borin, president of BD Medication Delivery Solutions, said, “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, BD has increased domestic manufacturing of syringes in our Nebraska and Connecticut facilities to respond to customer needs.”

Also Read: Medical Device Maker Becton Dickinson’s Q1 Earnings: Here’s Why This Analyst Is Bullish On Long-Term Prospects.

In November 2023, the FDA informed consumers, healthcare providers, and facilities that the FDA is evaluating the potential for device failures (such as leaks, breakage, and other problems) with plastic syringes manufactured in China that are used for injecting fluids into or withdrawing fluids from, the body. 

The agency said it received information about quality issues associated with several China-based manufacturers of syringes. The issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.

On Monday, the health regulator issued additional recommendations to U.S. suppliers, consumers, and healthcare organizations to immediately transition away from using plastic syringes manufactured by three Chinese companies.

The FDA cited three Chinese-based syringe manufacturers for regulator violations: Jiangsu Shenli Medical Production Co. Ltd, Medline Industries LP, and Sol-Millennium Medical Inc.

“We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance,” the FDA said in a statement on its website, adding that the evaluation is ongoing.

In January, the agency informed CNBC that it had received over 4,000 reports concerning problems with plastic syringes in 2023, clarifying that these reports encompassed syringes from various sources, not solely China. The agency acknowledged limitations in the data due to incomplete information and potential under-reporting. 

As part of its extensive investigation, CNBC examined numerous narratives from syringe medical device reports (MDRs) submitted to the FDA, aiming to uncover suspected issues or malfunctions linked to medical products.

Price Action: BDX shares are up 1.18% at $240.68 on the last check Thursday.

Illustration of Phrama lab worker created with MidJourney.