MIC-KEY Low-Profile Gastric-Jejunal Feeding Tube is a single-unit feeding and drainage system. It enters the stomach via a gastric stoma. A low-profile external support and an inflated balloon hold the tube in position (inside the stoma tract). The exterior bolster has two ports: one labeled "JEJUNAL" and one labeled "GASTRIC". Each port contains a one-way valve that is opened by adding the corresponding MIC-KEY Extension Set. MIC-KEY Extension Sets connect to the feeding and drain ports. The JEJUNAL port allows for feeding into the small intestine. The GASTRIC port is used to empty the stomach using modest intermittent suction or gravity drainage. To inflate and deflate the balloon, utilize a third port designated "BAL".

Features

• Tapered distal tip.
• Low-profile design.
• Proximal Anti-Reflux Valve.
• Multiple Gastric and Jejunal Exit Ports.
• Biocompatible silicone construction.
• Inflatable Silicone Internal Retention Balloon.
• Radiopaque Tungsten Weighted Jejunal Portion.
• SECUR-LOK Extension Set Connector Mechanism.

MIC-KEY Gastric-Jejunal Feeding Tube Kit Contents

• Gauze Pad
• Introducer Cannula
• 6ml Luer Tip Syringe
• Low-Profile GJ Feeding Tube
• 35 ml Enteral Feeding Syringe with ENFit Connector
• MIC-KEY Bolus Feed Extension Set with ENFit Connector, SECUR-LOK Straight Connector and Clamp 12 Inch
• MIC-KEY Continuous Feed Extension Set with 2 Port “Y” ENFit Connectors, SECUR-LOK Right Angle Connector and Clamp 12 Inch.

Indications for Use

AVANOS MIC-KEY Gastric-Jejunal Feeding Tube is recommended for patients with poor stomach absorption, intestinal motility issues, gastric outlet obstruction, severe gastroesophageal reflux, aspiration risk, or prior esophagectomy or gastrectomy.

Contraindications

Contraindications for placement of a gastric-jejunal feeding tube include, but are not limited to, ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity.

Warning

Do not reuse, reprocess, or resterilize this medical device. Reuse, reprocessing, or resterilization may

• Adversely affect the known biocompatibility characteristics of the device,
• Compromising the structural integrity of the device,
• Lead to the device not performing as intended, or
• Create a risk of contamination and cause the transmission of infectious diseases, resulting in patient injury, illness, or death.

Complications

The following complications may be associated with any Gastric-Jejunal Feeding Tube:

• Infection
• Perforation
• Hemorrhage
• Aspiration
• Intussusception
• Skin Breakdown
• Pressure Necrosis
• Intraperitoneal Leakage
• Hypergranulation Tissue
• Stomach or Duodenal Ulcers

Note: Verify package integrity. Do not use if the package is damaged or the sterile barrier compromised.

Note: The risk for perforation may be higher in patients weighing <10kg.

Placement

The AVANOS MIC-KEY Gastric-Jejunal Feeding Tube may be placed percutaneously under fluoroscopic or endoscopic guidance or as a replacement to an existing device using an established stoma tract. When removing an existing device, tract may be maintained by placing a guidewire in the indwelling tube before tube removal.

Warning: Used feeding tubes may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and all applicable local, state/provincial, and federal/national laws and regulations.

Caution: A gastropexy must be performed to affix the stomach to the anterior abdominal wall, the feeding tube insertion site identified, the stoma tract dilated and measured before initial tube insertion to ensure patient safety and comfort. The length of the tube should be sufficient to be placed 10–15 cm beyond the ligament of Treitz.

Caution: Do not use the retention balloon of the feeding tube as a gastropexy device. The balloon may burst and fail to attach to the stomach to the anterior abdominal wall.

Tube Preparation

• Select the appropriate size MIC-KEY Gastric-Jejunal Feeding Tube, remove from the package, and inspect for damage.
• Using the 6 ml Luer slip syringe contained in the kit, inflate the balloon with 5 ml sterile or distilled water through the balloon port.
• Remove the syringe and verify balloon integrity by gently squeezing the balloon to check for leaks. Visually inspect the balloon to verify symmetry. Symmetry may be achieved by gently rolling the balloon between the fingers. Reinsert the syringe and remove all the water from the balloon.
• Using a 6 ml Luer slip syringe, flush water through both the gastric and jejunal ports to verify patency.
• Lubricate the distal end of the tube with water-soluble lubricant. Do not use mineral oil or petroleum jelly.
• Generously lubricate the jejunal lumen with water-soluble lubricant. Do not use mineral oil or petroleum jelly.
• Insert the introducer cannula into the Jejunal port until the hub is in contact with the Jejunal feeding port and the introducer cannula is clearly visible inside the tube. The introducer cannula opens the one-way valve and protects it from damage by the guidewire.

Daily Care & Maintenance Checklist

Assess the patient

• Assess the patient for any signs of pain, pressure, or discomfort, warmth, rashes, or purulent or gastrointestinal drainage.
• Assess the patient for any signs of pressure necrosis, skin breakdown, or hypergranulation tissue.

Clean the stoma site

• Use warm water and mild soap.
• Use a circular motion, moving from the tube outwards.
• Clean sutures, external bolsters, and any stabilizing devices using a cotton-tipped applicator.
• Rinse thoroughly and dry well

Assess the tube

Assess the tube for any abnormalities such as damage, clogging, or abnormal discoloration.

Clean the feeding tube

• Use warm water and mild soap, being careful not to pull or manipulate the tube excessively.
• Rinse thoroughly, dry well.

Clean the jejunal, gastric, and balloon ports

Use a cotton tip applicator or soft cloth to remove all residual formula and medication.

Do not rotate the external bolster

This will cause the tube to kink and possibly lose position.

Verify placement of the external bolster

Verify that the external bolster rests 2–3mm above the skin.

Flush the feeding tube

• Flush the feeding tube with water every 4–6 hours during continuous feeding, anytime the feeding is interrupted, or at least every 8 hours if the tube is not being used.
• Flush the feeding tube after checking gastric residuals.
• Flush the feeding tube before and after medication administration.
• Avoid using acidic irrigants such as cranberry juice and cola beverages to flush feeding tubes.

Balloon Maintenance

Check the water volume in the balloon once a week.

• Insert a Luer slip syringe into the balloon inflation port and withdraw the fluid while holding the tube in place. Compare the amount of water in the syringe to the amount recommended or the amount initially prescribed and documented in the patient record. If the amount is less than recommended or prescribed, refill the balloon with the water initially removed, then draw up and add the amount needed to bring the balloon volume up to the recommended and prescribed amount of water. Be aware that as you deflate the balloon, there may be some gastric contents that can leak from around the tube. Document the fluid volume, the amount of volume to be replaced (if any), the date, and time.
• Wait 10–20 minutes and repeat the procedure. The balloon is leaking if it has lost fluid, and the tube should be replaced. A deflated or ruptured balloon could cause the tube to dislodge or be displaced. If the balloon is ruptured, it will need to be replaced. Secure the tube into position using tape, then follow facility protocol and/or call the physician for instructions.
• Note: Refill the balloon using sterile or distilled water, not air or saline. Saline can crystallize and clog the balloon valve or lumen, and air may seep out and cause the balloon to collapse. Be sure to use the recommended amount of water as over-inflation can obstruct the lumen or decrease balloon life and under-inflation will not secure the tube properly.

Balloon Longevity

Precise balloon life cannot be predicted. Silicone balloons generally last 1–8 months, but the life span of the balloon varies according to several factors. These factors may include medications, volume of water used to inflate the balloon, gastric pH and tube care.

MRI Safety Information

Non-clinical testing has demonstrated the Low-Profile (MIC-KEY*) Enteral Feeding Tube System is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:

• Static magnetic field of 1.5 Tesla or 3 Tesla;
• Maximum spatial field gradient of 1,960 G/cm (19.6 T/m) or less.
• The maximum MR system-reported whole-body-averaged specific absorption rate (SAR) is < 2 W/kg (Normal Operating Mode).

MRI-related heating: Under the scan conditions defined above, the LowProfile (MIC-KEY) Tube System is expected to produce a maximum temperature rise of less than 1.3 °C after 15 minutes of continuous scanning.

Artifact Information

In non-clinical testing, the image artifact caused by the device extends less than 45 mm from the Low-Profile (MIC-KEY*) Enteral Feeding Tube System when imaged with a gradient echo pulse sequence and a 3 T MRI system.