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.
周四，Becton Dickinson And Co（纽约证券交易所代码：BDX）表示，在美国食品药品管理局建议不要使用一些中国制造的注射器作为其正在进行的质量调查的一部分，因此增加了美国的医用注射器的产量。
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药物输送解决方案总裁埃里克·博林表示：“BD有能力支持额外的注射器需求，并正在进一步增加美国的产量，以帮助确保患者护理的连续性。自从美国食品和药物管理局于11月进行首次安全沟通以来，BD在内布拉斯加州和康涅狄格州的工厂增加了注射器的国内生产，以满足客户的需求。”
Also Read: Medical Device Maker Becton Dickinson's Q1 Earnings: Here's Why This Analyst Is Bullish On Long-Term Prospects.
另请阅读：医疗器械制造商贝克顿·狄金森的第一季度收益：这就是这位分析师看好长期前景的原因。
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告知消费者、医疗保健提供者和机构，FDA正在评估中国制造的用于向人体注射液体或从体内抽取液体的塑料注射器可能出现的设备故障（例如泄漏、破损和其他问题）。
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.
该机构表示，它收到了有关几家中国注射器制造商的质量问题的信息。该问题不包括玻璃注射器、预充式注射器或用于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.
周一，卫生监管机构向美国供应商、消费者和医疗保健组织发布了更多建议，要求他们立即停止使用三家中国公司生产的塑料注射器。
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.
美国食品药品管理局列举了三家中国注射器制造商的监管违规行为：江苏神力医疗生产有限公司。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.
美国食品药品管理局在其网站上的一份声明中说：“我们仍然担心在中国制造的某些注射器可能无法提供一致和足够的质量或性能，” 并补充说，评估仍在进行中。
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，该机构告知CNBC，它在2023年收到了4,000多份有关塑料注射器问题的报告，并澄清说，这些报告包括来自不同来源的注射器，而不仅仅是中国。该机构承认，由于信息不完整和可能漏报，数据存在局限性。
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.
作为广泛调查的一部分，CNBC审查了提交给美国食品药品管理局的注射器医疗器械报告（MDR）中的大量叙述，旨在发现与医疗产品有关的可疑问题或故障。
Price Action: BDX shares are up 1.18% at $240.68 on the last check Thursday.
价格走势：在周四的最后一次支票中，BDX股价上涨1.18％，至240.68美元。
Illustration of Phrama lab worker created with MidJourney.
使用 MidJourney 创作的 Phrama 实验室工作人员的插图。