Staff members at a Florida U.S. Veterans Affairs Dept. hospital reportedly said leadership ignored the recall of the Alaris infusion pump made by Becton Dickinson (NYSE:BDX). Leaders at the James Haley Veterans’ Hospital in Tampa dismissed repeated warnings about BD’s device over multiple weeks, even after a patient’s life was endangered, the Military Times reported. […]
BD updates infusion pump recalls
Becton Dickinson (NYSE:BDX) said today it has updated two voluntary recalls of certain Alaris infusion pump modules and infusion sets used with those modules. The FDA has designated both recalls as Class I, as the agency has received reports of several serious injuries associated with the recalled devices. The Alaris model 8100 modules were manufactured […]
BD recalls SmartSite syringe administration set
Becton Dickinson (NYSE:BDX) recalled nearly 3,000 leaky SmartSite syringe administration sets used in the neonatal intensive care unit in what the FDA deemed a Class I action. Franklin Lakes, N.J.-based BD issued an urgent medical device recall in February involving 2,900 of its SmartSite syringe administration sets, which are used with infusion pumps to deliver medication, […]
FDA panel wants more, better data on paclitaxel-eluting devices
An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]
FDA panel finds ‘smoking gun, but no bullet or dead bodies’ in paclitaxel devices
Members of an FDA advisory panel yesterday cited conflicting evidence from studies of paclitaxel-eluting devices in treating peripheral artery disease, with the panel’s chairman calling the data “a smoking gun, but no bullet or dead bodies at this particular point.” A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated […]
FDA: More data needed on paclitaxel devices
More data is needed on devices that elute the drug paclitaxel to determine if they pose a higher mortality risk than non-eluting devices in treating peripheral artery disease, the FDA said ahead of an advisory panel meeting today. A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated balloons […]
DHS warns again on cybersecurity flaw in BD’s Alaris infusion pump
The U.S. Homeland Security Dept. yesterday warned of two more cybersecurity vulnerabilities with the Alaris infusion pump made by Becton, Dickinson (NYSE:BDX). The DHS Industrial Control Systems Cyber Emergency Response Team, acting on weaknesses unearthed by researchers at CyberMDX, said the vulnerabilities could allow a malicious attacker to completely disable BD’s Alaris Gateway Workstation and install malware […]
Becton Dickinson cuts earnings outlook on paclitaxel warning
Becton Dickinson & Co. (NYSE:BDX) missed the consensus sales forecast for its fiscal second quarter and cut its outlook for the rest of the year, sending its share price down today on Wall Street. The cut to its earnings guidance is due to “recent regulatory and market pressures related to paclitaxel-coated devices,” Franklin Lakes, N.J.-based BD […]
BD launches second-gen ergonomic injection pen
Becton Dickinson & Co. (NYSE:BDX) said this week that its second-generation BD Nano pen needle won 510(k) clearance from the FDA. The company’s needles are designed to provide a more reliable subcutaneous injection depth, according to BD. Using a contoured needle base and distributed pressure, the pen needle lessens the risk resulting from user injection force […]
FDA releases BD lock flush syringe facility warning letter
The FDA this week released a warning letter it sent to Becton Dickinson (NYSE: BDX) last month over issues it found at the company’s Franklin, Wisc.-based facilities, which produces pre-filled Heparin and 0.9% sodium chloride lock flush syringes. The warning letter came from an inspection of the facilities which took place between May 16, 2018 and August […]
- 1
- 2
- 3
- 4
- Next Page »
Drug Delivery Business News
@DrugDeliveryNow
LinkedIn