• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » FDA requires nine makers of needleless connectors to conduct post-market surveillance

FDA requires nine makers of needleless connectors to conduct post-market surveillance

July 29, 2010 By MassDevice staff

FDA logo

The U.S. Food & Drug Administration said it is requiring nine medical device companies to conduct postmarket analysis on a connection between needless connectors and higher rates of blood stream infections.

In a notice posted on the Centers for Devices and Radiological Health web site, officials said that the agency is “aware of information that raises concerns about the safety of positive displacement needleless connectors.”

The devices are intended to allow connections of multiple IV sets and catheter hubs without the use of needles and allow the “delivery of a wide range of fluids to a patient’s vascular system through a cannula inserted into a vein or artery,” according to the FDA.

However, the federal watchdog said it has received reports of three deaths associated with blood stream infections and positive displacement needleless connectors.

In addition, the agency said there have been several clinical reports since 2006 showing, “an association between the introduction of positive displacement needleless connectors into a hospital or unit and an increased rate of BSI, followed by a reduction in BSI after changing to another type of needleless connector.”

Companies asked to particpate in the study are Baxter Healthcare Inc.(NYSE:BAX), Amsino International, Inc., Becton Dickinson Infusion Therapy Systems Inc. (NYSE:BDX), B. Braun Medical Inc., Cardinal Health, LLC (NYSE:CAH), Carefusion, Inc. (NYSE:CFN), Critical Device Corporation, ICU Medical, Inc. (NSDQ:ICU) and Medegen Medical Manufacturing Services.

Filed Under: Business/Financial News, News Well

More recent news

  • Medtronic escapes $106.5M payment in Colibri TAVR patent suit after court overturns jury verdict
  • RadNet closes iCAD acquisition, expands AI breast‑imaging portfolio
  • Hyperfine reports first commercial sales of next-gen AI-powered Swoop
  • Stereotaxis announces $12.5M offering
  • Nuwellis ends clinical trial of its ultrafiltration tech for heart failure

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy