FDA Probe On China-Made Syringes: Becton Dickinson Boosts US Syringe Output Following Concerns
FDA Probe On China-Made Syringes: Becton Dickinson Boosts US Syringe Output Following Concerns
Thursday, Becton Dickinson And Co (NYSE: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.
週四，Becton Dickinson And Co（紐約證券交易所代碼：BDX）表示，在美國食品藥品管理局建議不要使用一些中國製造的注射器作爲其正在進行的質量調查的一部分，因此增加了美國的醫用注射器的產量。
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."
BD藥物輸送解決方案總裁埃裏克·博林表示：“BD有能力支持額外的注射器需求，並正在進一步增加美國的產量，以幫助確保患者護理的連續性。自從美國食品和藥物管理局於11月進行首次安全溝通以來，BD在內布拉斯加州和康涅狄格州的工廠增加了注射器的國內生產，以滿足客戶的需求。”
Also Read: Medical Device Maker Becton Dickinson's Q1 Earnings: Here's Why This Analyst Is Bullish On Long-Term Prospects.
另請閱讀：醫療器械製造商貝克頓·狄金森的第一季度收益：這就是這位分析師看好長期前景的原因。
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.
2023年11月，FDA告知消費者、醫療保健提供者和機構，FDA正在評估中國製造的用於向人體注射液體或從體內抽取液體的塑料注射器可能出現的設備故障（例如泄漏、破損和其他問題）。
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.
該機構表示，它收到了有關幾家中國注射器製造商的質量問題的信息。該問題不包括玻璃注射器、預充式注射器或用於口服或局部用途的注射器。
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.
週一，衛生監管機構向美國供應商、消費者和醫療保健組織發佈了更多建議，要求他們立即停止使用三家中國公司生產的塑料注射器。
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.
美國食品藥品管理局列舉了三家中國注射器製造商的監管違規行爲：江蘇神力醫療生產有限公司。有限公司、Medline Industries LP 和 Sol-Millennium Medical
"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.
美國食品藥品管理局在其網站上的一份聲明中說：“我們仍然擔心在中國製造的某些注射器可能無法提供一致和足夠的質量或性能，” 並補充說，評估仍在進行中。
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.
1月，該機構告知CNBC，它在2023年收到了4,000多份有關塑料注射器問題的報告，並澄清說，這些報告包括來自不同來源的注射器，而不僅僅是中國。該機構承認，由於信息不完整和可能漏報，數據存在侷限性。
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.
作爲廣泛調查的一部分，CNBC審查了提交給美國食品藥品管理局的注射器醫療器械報告（MDR）中的大量敘述，旨在發現與醫療產品有關的可疑問題或故障。
Price Action: BDX shares are up 1.18% at $240.68 on the last check Thursday.
價格走勢：在週四的最後一次支票中，BDX股價上漲1.18％，至240.68美元。
Illustration of Phrama lab worker created with MidJourney.
使用 MidJourney 創作的 Phrama 實驗室工作人員的插圖。