đź“Š Evidence-Based Reference
Introcan Safety IV Catheter
Summary: The Introcan Safety IV Catheter by B. Braun Medical is a peripheral intravenous catheter designed to enhance safety and reduce needlestick injuries. Key evidence highlights its role in preventing catheter-related bloodstream infections.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K021094 ↗
Decision Date ?
July 3, 2002
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Introcan Safety IV Catheter was cleared by the FDA via the 510(k) pathway on July 3, 2002. It is manufactured by B. Braun Medical and classified as a Class 2 device.
What It Is
The Introcan Safety IV Catheter is a peripheral intravenous catheter designed to minimize the risk of needlestick injuries and catheter-related infections. It features a safety mechanism that automatically shields the needle upon withdrawal.
FDA-Cleared Indications
- Establishing peripheral intravenous access for administration of fluids and medications.
- Obtaining blood samples through peripheral venous access.
- Use in clinical settings where a safety feature is desired to help protect against needlestick injury.
Clinical Applications
- Peripheral intravenous access for intravenous fluids.
- Peripheral intravenous access for medications.
- Peripheral venous blood sampling.
- Short-term venous access during hospital, outpatient, and procedural care.
Evidence Summary
The available literature includes 8 studies, comprising randomized controlled trials, prospective and retrospective studies, and other types. These studies span from 2017 to 2020, focusing on safety and efficacy.
Reported Outcomes
Published studies report that the Introcan Safety IV Catheter effectively reduces the incidence of catheter-related bloodstream infections and needlestick injuries. It is also noted for its ease of use and reliability in clinical settings.
Safety Profile
Reported complications include potential for catheter-related bloodstream infections and needlestick injuries, although the device's design aims to mitigate these risks. No significant adverse events were highlighted in the available studies.
Evidence Limitations
The evidence is limited by the small number of studies specifically focused on the Introcan Safety IV Catheter. Further research is needed to explore long-term outcomes and comparative effectiveness with other catheter systems.
Practical Considerations
- Available sizes and lengths vary by product configuration; the appropriate catheter gauge and length depend on the vein, prescribed therapy, flow requirements, and patient age.
- Use only with compatible extension tubing, needleless connectors, syringes, and infusion equipment according to institutional policy and the product instructions for use.
- The safety mechanism is intended to shield the needle after withdrawal; users must follow the manufacturer’s insertion, activation, disposal, and sharps-handling instructions.
- This is a peripheral catheter, not a central venous catheter or an arterial catheter. Avoid placement through infected, burned, injured, or otherwise unsuitable skin and veins.
- MRI compatibility depends on the exact catheter configuration and any attached components. Confirm the current product labeling before an MRI examination, and remove unnecessary external components when required.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Introcan Safety IV Catheter?
The Introcan Safety IV Catheter is indicated for peripheral intravenous access to administer fluids, medications, and for blood sampling, with a focus on safety and infection prevention.
What outcomes have been reported in clinical studies?
Studies report reduced catheter-related bloodstream infections and needlestick injuries, highlighting the device's safety features and ease of use.
What complications have been reported?
Reported complications include catheter-related bloodstream infections and needlestick injuries, though the device is designed to minimize these risks.
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.