📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitates placement of peripherally inserted central catheters.
- Provides access for establishing central venous access through a peripheral vein.
Clinical Applications
- Introducing a PICC through a peripheral upper-extremity vein.
- Supporting placement of central venous access for prolonged intravenous infusion therapy.
- Use during PICC placement in patients who require central access, including adults and neonatal patients when clinically appropriate.
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.
Practical Considerations
- Available sizes, lengths, dilators and guidewire compatibility should be confirmed in the product-specific instructions for use; this FDA record does not provide a complete size list.
- The introducer is used during catheter placement and is generally removed after the PICC has been advanced and positioned; it is not the long-term indwelling PICC itself.
- Placement is typically performed using sterile technique, local anesthesia with or without sedation, and ultrasound and/or fluoroscopic guidance according to patient age, anatomy and institutional practice.
- Before use, clinicians should assess for infection at the access site, venous thrombosis, severe vascular abnormalities, coagulopathy and other contraindications to central venous access.
- MRI safety depends on the exact materials and configuration of the introducer and any retained catheter. The product-specific labeling should be reviewed; temporary introducers are normally removed before MRI.
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.