Becton Dickinson & Co 8-K, filed Apr 26, 2021
Becton Dickinson & Co (BDX)
8-K
2021-04-26
For: 2021-04-26
View Original
Added on
April 12, 2026
About this 8-K
Becton Dickinson & Co filed this 8-K on April 26, 2021.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT TO
SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) April 26, 2021
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ITEM 7.01 Regulation FD Disclosure
On April 26, 2021, Becton, Dickinson and Company (“BD”) issued a press release announcing it submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for the BD Alaris™ System.
The 510(k) submission is intended to bring the regulatory clearance for the BD Alaris™ System up to date, implement updated features and address open recall issues, including through a new version of BD Alaris™ System software that will provide clinical, operational and cybersecurity updates.
The press release is attached as Exhibit 99.1. The information in this Item 7.01 and in Exhibit 99.1 to this Current Report on Form 8-K is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities thereof, nor shall it be incorporated by reference into future filings by BD under the Exchange Act or under the Securities Act of 1933, as amended, except to the extent specifically provided in any such filing.
ITEM 9.01 Financial Statements and Exhibits.
Exhibit 99.1 Press release dated April 26, 2021, which is furnished pursuant to Item 7.01.
Exhibit 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
BECTON, DICKINSON AND COMPANY
(Registrant)
| By: | /s/ Gary DeFazio | ||||
| Gary DeFazio | |||||
| Senior Vice President and Corporate Secretary | |||||
Date: April 26, 2021
NEWS RELEASE FOR IMMEDIATE RELEASE
BD Announces FDA 510(k) Submission for BD Alaris™ System
FRANKLIN LAKES, N.J. (April 26, 2021) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the BD Alaris™ System, the most widely used infusion pump in acute care hospitals across the United States.
The 510(k) submission is intended to bring the regulatory clearance for the BD Alaris™ System up to date, implement updated features and address open recall issues, including through a new version of BD Alaris™ System software that will provide clinical, operational and cybersecurity updates.
“Today marks an important milestone in our commitment to our customers and patients and Advancing the world of health™,” said Michael Garrison, worldwide president of Medication Management Solutions for BD. "The 510(k) submission is the first step in the review process with the FDA, and we look forward to working through the FDA review process to obtain clearance for the updated BD Alaris™ System.”
The BD Alaris™ System allows clinicians to deliver medications, fluids and blood products through a single integrated platform that includes large volume pumps, syringe pumps and patient-controlled analgesia (PCA) modules for adult, pediatric and neonatal patients.
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About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ and Twitter @BDandCo.
Forward Looking Statements
This press release contains certain forward-looking statements regarding BD’s 510(k) premarket notification to the FDA for the BD Alaris™ System. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, and there can be no assurance that BD will obtain 510(k) clearance from the FDA for the BD Alaris™ System or as to the timing of any such clearance. Many of these risks and uncertainties are beyond the company's control, including without limitation, risks relating to regulatory clearance and market acceptance of the BD Alaris™ System, the remediation of our infusion pump business and other factors listed in our 2020 Annual Report on Form 10-K and other filings with the SEC. BD expressly disclaims any undertaking to update any forward-looking statements set forth herein to reflect events or circumstances after the date hereof, except as required by applicable laws or regulations.
Contacts:
Media Investor Relations
Media Investor Relations
Troy Kirkpatrick Kristen M. Stewart, CFA
VP, Public Relations SVP, Strategy & Investor Relations
858.617.2361 201.847.5378
troy.kirkpatrick@bd.com kristen.stewart@bd.com
VP, Public Relations SVP, Strategy & Investor Relations
858.617.2361 201.847.5378
troy.kirkpatrick@bd.com kristen.stewart@bd.com