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introcan safety iv catheter
B. Braun Medical
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 510K
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.
Clinical Applications
Commonly used in hospital and clinical settings, the Introcan Safety IV Catheter is employed for intravenous access to administer fluids, medications, and for blood sampling. It is particularly useful in scenarios requiring enhanced safety measures.
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.
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.