đź“Š Evidence-Based Reference
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 ?
510(k)
Number ?
K870075 ↗
Decision Date ?
April 27, 1987
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheterization of a central vein for access to the central venous circulation.
- Administration of medications, fluids, blood products, or other intravenous treatments through central venous access.
- Prolonged intravenous access when peripheral venous access is inadequate or unsuitable.
Clinical Applications
- Central venous access through the internal jugular, subclavian, or femoral vein.
- Administration of intravenous medications and fluids.
- Administration of blood products.
- Delivery of parenteral nutrition when prolonged central venous access is required.
- Central venous pressure or hemodynamic monitoring when the catheter configuration supports it.
Reported off-label uses
- Central venous access for procedures or treatments not specifically described in the device labeling, when selected and used by a qualified clinician.
- Use as temporary access for specialized extracorporeal treatments with a catheter designed and labeled for that purpose.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- Catheters are available in different lengths, diameters, lumen numbers, and configurations; selection depends on the access vein, treatment, flow requirements, and expected duration.
- Placement should use sterile technique and image guidance when appropriate. The tip position should be confirmed according to institutional practice before use.
- Compatibility with medications, contrast agents, pressure injection, and blood products depends on the specific catheter design and labeling.
- MRI safety is device-specific. The catheter and any attached components should be checked in the FDA labeling or manufacturer documentation before MRI.
- Important risks include infection, thrombosis, bleeding, arterial puncture, catheter malposition, vessel injury, air embolism, arrhythmia, and rare cardiac perforation or tamponade.
Procedures that use this device
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.