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central venous catheter
Bd Becton Dickinson Vacutainer Systems Preanalytic
Summary: A central venous catheter is used for vascular access in clinical treatments. Key evidence highlights rare complications like malposition and cardiac tamponade.
FDA Clearance Information
Pathway 510K
Number K870075 ↗
Decision Date April 27, 1987
Product Code DQY
Device Class Class 2
Evidence 0 studies
The central venous catheter by Bd Becton Dickinson Vacutainer Systems Preanalytic was cleared by the FDA via the 510k pathway on April 27, 1987. It is classified as a Class 2 device.
What It Is
A central venous catheter is a medical device inserted into a large central vein to provide prolonged access to the central venous circulation. It is used for administering medications, fluids, and blood products.
Clinical Applications
Commonly used in scenarios requiring long-term intravenous therapy, such as chemotherapy, parenteral nutrition, and hemodynamic monitoring. It provides access to the internal jugular, subclavian, or femoral veins.
Evidence Summary
The literature includes 15 studies, comprising case series and reviews, published between 2020 and 2024. These studies explore various complications and procedural techniques associated with central venous catheters.
Reported Outcomes
Published studies report that central venous catheters are effective for providing vascular access for various treatments. However, rare complications such as malposition and cardiac tamponade have been documented, with significant mortality associated with the latter.
Safety Profile
Reported complications include mechanical issues, infections, thromboembolic events, and rare occurrences of cardiac tamponade. The use of ultrasound guidance has been shown to reduce some mechanical complications.
Evidence Limitations
The evidence is limited by the rarity of some complications, leading to a reliance on case series and retrospective reviews. Further research is needed to quantify risks and optimize procedural techniques.
Frequently Asked Questions
What are the clinical indications for central venous catheter?
Indications include long-term intravenous therapy, hemodynamic monitoring, and administration of medications, fluids, and blood products.
What outcomes have been reported in clinical studies?
Studies report effective vascular access with rare complications such as malposition and cardiac tamponade.
What complications have been reported?
Safety data indicate complications like mechanical issues, infections, thromboembolic events, and cardiac tamponade.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.