This post-market study is being conducted to generate safety and performance data on the SiteRite 9 System. The data will be utilized to support regional registrations (for example, EU MDR), and document any unforeseen residual risks.
This is an observational post-market, human subject study to evaluate the safety and performance of the SiteRite 9 System. Subjects will be recruited for participation based on need for Vascular Access Device (VAD) placement in a hospital setting. Enrolled subjects will go through ultrasound-guided Vascular Access Device (USGVAD) placement as part of their clinical care. USGVAD is defined as a procedure in which an ultrasound machine is used to assist a qualified health care provider with IV cannulation from skin puncture through venipuncture via direct visualization on the ultrasound machine in real time.
Study Type
OBSERVATIONAL
Enrollment
149
Ultrasound-guided vascular access device placement procedure using the BD SiteRite(TM) 9.
Brookdale University Hospital & Medical Center
Brooklyn, New York, United States
Primary Performance: To provide visualization of the target vessel in which to insert the chosen vascular access device.
The BD SiteRiteTM 9 Ultrasound System is able to visualize the target vasculature (\>=70% with a 95% confidence interval)
Time frame: During the procedure
Primary Performance: To have successful vascular access either by cannulation or blood return.
Successful access with the vascular access device, either by cannulation or blood return (\>=70% with a 95% confidence interval)
Time frame: During the procedure
Primary Safety: To determine the incidence of device related adverse events, experienced by patient or user, when using the BD SiteRiteTM 9 Ultrasound System.
Rate of device related adverse events (\<2%).
Time frame: During the procedure and 15 minutes after the procedure
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