MIC-KEY Low-Profile Gastrostomy Feeding Tube is a step up from traditional gastrostomy tubes. The MIC-KEY feeding tube is extremely popular and commonly prescribed since it is subtle and simple to hide, making it appropriate for almost everyone. It is discreet and simple to conceal. The little exterior surface area enables air circulation around the stoma. Ease of care promotes patient participation and independence. Also reduces the possibility of gastric leaks.

Features

• Radiopaque stripe.
• Proximal anti-reflux valve.
• FDA-approved and CE-marked.
• Tapered distal tip recessed at the appropriate fill volume.
• The low-profile design makes it inconspicuous and easy to hide.
• The high clarity medical grade silicone structure is intended for visibility and drapability.
• For active individuals, these tubes are less burdensome than standard gastrostomy tubes.
• Patented universal connection is designed to extend tube life and reduce inadvertent disconnects.
• Inflatable silicone internal retention balloons prevent patient stress associated with obturated devices.
• The ventilated secur-lok ring is an external retention device that allows air to circulate around the stoma site and reduces tube pressure from all sides of the stoma wall.

MIC-KEY Low-Profile Gastrostomy Feeding Tube Kit Contents:

• 1) MIC-KEY Gastrostomy Feeding Tube (Low-Profile G-Tube)
  • Balloon Valve, Feeding Valve Cover, Balloon Cuff, Feeding/Medication Valve, Balloon, External Base, Balloon Tip, Shaft
• 1) 6 ml Luer Slip Syringe
• 1) 35 ml Catheter Tip Syringe
• 1) MIC-KEY Continuous Feed Extension Set with SECUR-LOK Right Angle Connector with 2 Port “Y” and Clamp 12 (i.e., Right Angle Extension Set)
  • Feeding Port Plug, Medication Port Plug, Feeding Port, SECUR-LOK Connector, Medication Port
• 1) MIC-KEY Bolus Feed Extension Set with Cath Tip, SECUR-LOK Straight Connector and Clamp 12 (i.e., Bolus Extension Set)
  • Bolus Feeding Port
  • SECUR-LOK Connector
• 4) Gauze Pads
• 1) MIC-KEY Insertion Stylet
• 1) Water-Soluble Lubricant

Indications For Use

The AVANOS MIC-KEY Low-Profile Gastrostomy Feeding Tube is indicated for use in patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration, require gastric decompression, and/or medication delivery directly into the stomach.

Warning: For enteral nutrition and/or medication only. Please use caution: breathing systems and driving gases, urethral/urinary, limb cuff inflation, neuroaxial, and intravascular/hypodermic connectors may have the potential for misconnection.

Contraindications

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

Complications

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

The following complications may be associated with any low-profile gastrostomy feeding tube:

• Skin Breakdown, Infection, Hypergranulation Tissue, Stomach or Duodenal Ulcers, Intraperitoneal Leakage, Pressure Necrosis

Placement

The Avanos MIC-KEY Low-Profile Gastrostomy Feeding Tube may be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance or as a replacement to an existing device using an established stoma tract.

Warning: A gastropexy must be performed to affix the stomach to the anterior abdominal wall, the Feeding Tube insertion site identified, stoma tract dilated and measured before initial tube insertion to ensure patient safety and comfort.

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. The insertion site for infants and children should be high on the greater curvature to prevent occlusion of the pylorus when the balloon is inflated.

An inappropriately sized MIC-KEY can cause necrosis, buried bumper syndrome, and/or hypergranulation tissue.

Balloon Verification

• Select the appropriate size MIC-KEY Gastrostomy 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 the appropriate amount of sterile or distilled water through the balloon valve. Caution: Do not use air or saline. Refer to the following table for the recommended inflation for the French size of the device.

Inflation Table

Size	Recommended Fill Volume	Maximum Fill Volume
12 Fr	3 ml	5 ml
14 Fr	5 ml	10 ml
16 Fr	5 ml	10 ml
18 Fr	5 ml	10 ml
20 Fr	5 ml	10 ml
24 Fr	5 ml	10 ml

• 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.
• Lubricate the balloon tip with a water-soluble lubricant. Caution: Do not use mineral oil. Do not use petroleum jelly.

Daily Care & Maintenance Check List

Assess the patient: Assess the patient for any signs of pain, pressure, or discomfort.

Assess the stoma site

• Assess the patient for any signs of infection, such as redness, irritation, edema, swelling, tenderness, 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 Feeding Tube outwards.
• Clean sutures, external base, and any stabilizing devices using a cotton-tipped applicator.
• Rinse thoroughly and dry well.

Assess the MIC-KEY

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

Clean the MIC-KEY

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

Verify placement of the external base

Verify that the external base 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 carbonated soft drinks to flush Feeding Tubes.

Balloon Maintenance

Check the water volume in the balloon once a week.

• Insert a Luer slip syringe into the balloon valve and withdraw the fluid while holding the Feeding 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 Feeding 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 Feeding Tube should be replaced. A deflated or ruptured balloon could cause the Feeding Tube to dislodge or be displaced. If the balloon is ruptured, it will need to be replaced. Secure the Feeding Tube into position using tape, then follow facility protocol and/or call the physician for instructions.
• Caution: Refill the balloon using sterile or distilled water, not air or saline. Saline can crystallize and clog the balloon valve, and air may seep out and cause the balloon to collapse. Be sure to use the recommended amount of water, as overinflation can decrease balloon life, and underinflation will not secure the Feeding 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 feeding tube care.

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