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first picc introducer catheter
Becton Dickinson Vascular Access
Summary: The first PICC introducer catheter by Becton Dickinson is used for peripherally inserted central catheter placement. It is FDA 510k cleared and supported by studies highlighting its use in neonates and adults, focusing on insertion techniques and safety.
FDA Clearance Information
Pathway
510K
Number
K954906 ↗
Decision Date
April 8, 1996
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The first PICC introducer catheter was cleared by the FDA through the 510k pathway on April 8, 1996. Manufactured by Becton Dickinson Vascular Access, it is classified as a Class 2 device.
What It Is
The first PICC introducer catheter is designed to facilitate the placement of peripherally inserted central catheters (PICCs). It is used to provide central venous access for prolonged infusion therapy, offering a less invasive alternative to traditional central venous catheters.
Clinical Applications
This device is commonly used in clinical settings for patients requiring long-term intravenous therapy, such as chemotherapy or antibiotic administration. It is particularly useful in neonates and adults where central venous access is necessary but traditional methods pose higher risks.
Evidence Summary
The available literature includes three studies, ranging from 2016 to 2025, encompassing various study designs such as RCTs and case series. These studies focus on insertion techniques and safety in both neonates and adults.
Reported Outcomes
Published studies report that the first PICC introducer catheter is effective in facilitating PICC placement with improved safety and ease of use. In neonates, a novel insertion technique using a fine-tipped introducer cannula has shown promising results. In adults, optimized techniques have reduced mechanical complications during insertion.
Safety Profile
Reported complications include mechanical issues such as shearing of the peel-away sheath during insertion. However, advancements in insertion techniques have mitigated some of these risks, particularly in neonates and adults.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and compare different insertion techniques across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for first PICC introducer catheter?
The device is indicated for the placement of peripherally inserted central catheters, particularly in patients requiring long-term intravenous therapy.
What outcomes have been reported in clinical studies?
Studies have reported effective PICC placement with improved safety and ease of use, particularly with novel insertion techniques in neonates and adults.
What complications have been reported?
Safety data indicate mechanical complications such as shearing of the peel-away sheath, though improved techniques have reduced 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.