NeoMed Silicone Nasogastric Feeding Tube with ENFit Connector should be designed to reduce tissue trauma, which is common with oversized sharp side port holes and sharp unfinished distal tips. Distal tips should be smooth, well formed and open. Exposed surfaces should be accessible and easily cleaned. Bacteria growth and transfer is often attributed to material pooling within closed distal tips, poor bifurcated hub designs and nonswabbable, recessed or threaded hub caps.

Features

• BPA free.
• ENFit compliant
• Three offset side port holes are precision drilled to provide smooth edges
• Soft medical grade polymers support quality developmental care and improved outcomes
• Cost-effective solution providing indwell time up to 30 days, minimizing need for additional tube placements
• Open distal tip with no sharp edges or hidden cavities eliminates residual colonization associated with closed tip feeding tubes

Intended Users: This device is intended to be used by healthcare professionals.

Patient Target Group: This device is intended to be used in patients of all age groups who require nasogastric/oralgastricenteral feeding.

Indications for Use: This product is intended for use in neonatal and pediatric patients to provide nutrition via nasal and oral gastric placement and is not intended for use beyond 30 days.

Contraindications: This device is intended to connect to products with ENFit® compatible connectors. This device is not intended for use longer than 30 days. This device is not intended for use in patients with congenital anomalies of the GI tract above the stomach requiring surgical intervention.

Device Description / Intended Purpose: The NEOMED Enteral Feeding Tube is intended for use in patients who require intermittent or continuous tube feedings via the nasogastric or oralgastric pathway. Material options include Silicone. Refer to product packaging for product specific information.

Residual Risks and Side Effects: While side effects vary depending on the type of procedure performed, mitigations have been implemented to minimize the following residual risks related to the use of the NEOMED.

Nasogastric Feeding Tubes and the associated NEOMED Extension Sets: abnormal reproductive development, allergic/ systemic toxic reaction, over/under delivery of medication (potentially life-threatening)/nutrition, skin/tissue damage/ irritation (includes trachea, vocal cords, gastrointestinal tract/ ulcer/necrosis), infection/fever/sepsis, nausea/vomiting/ bloating/diarrhea, delayed or prolonged treatment/procedure/ therapy, pneumothorax, choking, long-term carcinogenic and/ or mutagenic effects, aspiration, peritonitis, gastroenteritis, laceration, pain.

MR Information

MR Safe

The NEOMED Enteral Feeding Tube contains only nonconducting, nonmetallic and non magnetic items and poses no known hazards in all MR imaging environments.

Clinical Benefits: Nasogastric/ Oralgastric Feeding Tubes shall facilitate nutrition (and fluid and medication) delivery to stomach via the nose or mouth.

Device Lifetime: Device has been validated for use for up to 30 days.

Recommended Placement Procedure

Insertion Measurement: measure from the tip of the nose to the earlobe and then from the earlobe to midway between the xyphoid process and umbilicus. Centimeter markings are provided on the catheter to assist in the feeding tube placement.

A strip of sterile tape can be placed at the target insertion depth of the feeding tube for reference.

Insert the tube slowly and cautiously into the mouth or nose (lubricant is optional); allow the infant to swallow as the tube is advanced.

Continue to advance to the predetermined length.

Precautions: avoid inadvertent placement of the tube into the trachea or inadequate insertion such that the proximal side hole is not fully placed in the stomach. Secure the feeding tube either by holding the tube or taping to the patient before checking for placement.

Verify Feeding Tube Placement: Finalize securement, and verify and document according to hospital protocol (e.g., chest radiograph, aspiration of gastric contents / pH testing). If the tip placement remains uncertain reposition or remove.

Recommended Maintenance

The feeding tube should be visually checked for correct position before each administration utilizing tube markings.

Verify proper tube placement before each administration according to hospital protocol.

Flush feeding tube with sterile water before and after each administration.

Plug feeding tube with tethered closure when not in use.

Recommended Feeding Tube Removal

Flush the feeding tube with 0.5cc–1cc of sterile water.

Plug with tethered closure and/or clamp the feeding tube during tube removal to minimize the risk of aspirating fluids into the trachea during withdrawal.

Gently and slowly withdraw the feeding tube and discard per standard hospital protocol and/or local or national regulations.

Document the feeding tube removal.

Disposal: Contact the local authorities to determine the proper method of disposal of potentially biohazardous parts and accessories. Disposal of the device and accessories should be in accordance with local, state, and national laws and regulations.