📊 Evidence-Based Reference
Safety Introducer Needle
Summary: The safety introducer needle by B. Braun Medical is primarily used for vascular access procedures. Key evidence highlights its role in minimizing complications during catheter insertions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K030135 ↗
Decision Date ?
July 15, 2003
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The safety introducer needle was cleared by the FDA via the 510(k) pathway on July 15, 2003. Manufactured by B. Braun Medical, it is classified as a Class 2 device.
What It Is
The safety introducer needle is a medical device designed for facilitating vascular access. It is used to introduce catheters into blood vessels, ensuring safe and effective placement.
FDA-Cleared Indications
- Facilitation of vascular access for the introduction of catheters and other intravascular devices.
- Use during procedures in which a needle is required to access a blood vessel.
Clinical Applications
- Obtaining percutaneous vascular access before catheter-based treatment.
- Introducing vascular catheters used for diagnostic angiography.
- Establishing access for endovascular procedures, including embolization and other catheter-directed treatments.
- Obtaining vascular access in hospital, intensive-care, surgical and interventional procedure settings.
Evidence Summary
The literature includes 14 studies, comprising various study types such as RCTs and case series, conducted between 2023 and 2025. These studies explore the device's efficacy and safety.
Reported Outcomes
Published studies report that the safety introducer needle effectively facilitates catheter placement with minimal complications. It is noted for its precision in vascular access, reducing the risk of intravascular retention of fragments.
Safety Profile
Reported complications include the potential for intravascular retention of fragments if the needle is improperly manipulated. Studies emphasize the importance of using ultrasonography to prevent and manage such events.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for more diverse clinical settings. Further research is needed to explore long-term outcomes and broader applications.
Practical Considerations
- The available needle size, length and configuration should match the target vessel, access technique and catheter or guidewire system.
- Use requires sterile technique and appropriate imaging or anatomic guidance to reduce bleeding, arterial injury and other access-site complications.
- Compatibility with the intended guidewire, catheter and introducer system should be confirmed before use.
- MRI safety depends on the specific needle and whether it remains in the patient; consult the current product labeling rather than assuming MRI compatibility.
- Potential complications include bleeding, hematoma, infection, vessel injury, pseudoaneurysm and accidental puncture of an adjacent structure.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for safety introducer needle?
The safety introducer needle is indicated for use in vascular access procedures, particularly for introducing catheters in embolization-coil placements.
What outcomes have been reported in clinical studies?
Studies report effective catheter placement with reduced risk of complications, highlighting the needle's precision in vascular access.
What complications have been reported?
Safety data indicate potential complications such as intravascular retention of fragments, particularly if the needle is reinserted improperly.
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.