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FDA Investigates China-Made Syringes: Becton Dickinson Ramps Up US Production Amid Safety Concerns Ensuring Patient Safety: Becton Dickinson Steps Up US Syringe Output after FDA Warnings

Thursday, Becton Dickinson And Co BDX disclosed a surge in the production of medical syringes in the United States following FDA restrictions on certain China-made syringes amidst an ongoing quality review.

Eric Borin, president of BD Medication Delivery Solutions, reassured, “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 FDA’s safety communication in November, BD has ramped up domestic manufacturing of syringes in our Nebraska and Connecticut facilities to meet customer requirements.”

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In November 2023, the FDA alerted consumers, healthcare providers, and facilities about potential device malfunctions (like leaks, breakage, among others) of plastic syringes produced in China used for fluid administration or withdrawal from the body.

The FDA noted quality concerns related to several Chinese syringe manufacturers. Glass syringes, pre-filled syringes, or syringes for oral or topical use are not implicated in this issue.

On Monday, the FDA issued further guidelines to U.S. suppliers, consumers, and healthcare institutions to discontinue the use of plastic syringes made by three Chinese firms immediately.

The FDA sanctioned three Chinese syringe manufacturers – Jiangsu Shenli Medical Production Co. Ltd, Medline Industries LP, and Sol-Millennium Medical Inc., for regulatory breaches.

“There are lingering concerns regarding the consistent quality and performance of certain Chinese-made syringes,” stated the FDA on its website, emphasizing that the investigation continues.

In January, the FDA informed CNBC that it had received over 4,000 complaints concerning issues with plastic syringes in 2023, clarifying that these reports encompassed syringes from various sources, not solely China, acknowledging data limitations due to incomplete information and potential underreporting.

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As part of its comprehensive investigation, CNBC scrutinized numerous narratives from syringe medical device reports submitted to the FDA to unearth suspected issues or malfunctions associated with medical products.

Market Performance: BDX shares are up 1.18% at $240.68 at the time of the latest check on Thursday.

Illustration of Pharma lab worker crafted with MidJourney.