Avanos Medical 0270-16-4.0-45 - MIC-KEY Gastric-Jejunal Feeding Tube Kit - 16 Fr, 4.0 cm - 45 - Non-ENFit, 1 EA/CS

Avanos Medical 0270-16-4.0-45 - MIC-KEY Gastric-Jejunal Feeding Tube Kit - 16 Fr, 4.0 cm - 45 - Non-ENFit, 1 EA/CS

Avanos 0270-16-4.0-45 MIC-KEY Gastric-Jejunal Feeding Tube Kit

The MIC-KEY Gastric-Jejunal Feeding Tubes are designed for pediatric and adult patients requiring simultaneous jejunal feeding and gastric decompression. Proper support is provided by utilizing multiple jejunal exit ports to improve flow and minimize clogging. The tubes are weighted and have high columnar strength to help maintain position in the jejunum, making maintenance easier for the caregiver by decreasing the need for tube repositioning.

The MIC-KEY GJ Feeding Tubes are available in low-profile and conventional designs. Strategic FeaturesThe MIC-KEY GJ Feeding Tubes offer multiple feeding exit ports, a jejunal port, and a gastric decompression port. The gastric and jejunal ports are clearly marked to ease with identification. Plus, a radiopaque stripe is included to aid in catheter visualization. The high-clarity medical grade silicone construction is designed to improve visibility and drapability. The wide range of sizes and lengths ensure an accurate fit for the patients.

Avanos0270-16-4.0-45 MIC-KEY Gastric-Jejunal Feeding Tube Kit Features

• Medical grade silicone construction
• Low-profile design
• Silicone internal retention balloon
• Gastric decompression port
• Multiple Gastric and Jejunal exit ports
• Radiopaque weighted Jejunal portion
• SECUR-LOK extension set connector mechanism
• Tapered distal tip
• Radiopaque stripe

Avanos0270-16-4.0-45 MIC-KEY Gastric-Jejunal Feeding Tube Kit Contents:

• 1 Low-Profile Gastric-Jejunal Feeding Tube
• 1 Introducer Cannula
• 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 and 2 Port "Y" and Clamp 12
• 1 MIC-KEY Bolus Feed Extension Set with Cath Tip, SECUR-LOK Straight
• Connector and Clamp 12
• 4 Gauze Pads

Indications For Use of Avanos0270-16-4.0-45 MIC-KEY Gastric-Jejunal Feeding Tube

The AVANOS MIC-KEY Gastric-Jejunal Feeding Tube is indicated for use in patients who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous 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 1) adversely affect the known biocompatibility characteristics of the device, 2) compromise the structural integrity of the device, 3) lead to the device not performing as intended, or 4) create a risk of contamination and cause the transmission of infectious diseases resulting in patient injury, illness, or death.

Avanos MIC-KEY Gastric-Jejunal Feeding Tube Preparation

1. Select the appropriate size MIC-KEY Gastric-Jejunal Feeding Tube, remove from the package and inspect for damage.

2. 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. (Fig 1-A)

3. 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.

4. Using a 6 ml Luer slip syringe, flush water through both the gastric and jejunal ports (Fig 1-A & B) to verify patency.

5. Lubricate the distal end of the tube with water-soluble lubricant. Do not use mineral oil or petroleum jelly.

6. Generously lubricate the jejunal lumen with water-soluble lubricant. Do not use mineral oil or petroleum jelly.

7. Insert the introducer cannula (Fig 5) 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.

Avanos MIC-KEY Gastric-Jejunal Feeding Tube Placement

Note: A peel-away sheath may be used to facilitate advancement of the tube through the stoma tract.

1. Select the appropriate MIC-KEY Gastric-Jejunal Feeding Tube and prepare according to the directions in the Tube Preparation section listed above.

2. Advance the distal end of the tube over the guidewire until the proximal end of the guidewire exits the introducer cannula. Note: Direct visualization and manipulation of the introducer and guidewire may be required to pass the guidewire through the end of the introducer.

3. Hold the introducer hub and jejunal feeding port while advancing the tube over the guidewire and into the stomach.

4. Rotate the AVANOS MIC-KEY Gastric-Jejunal Feeding Tube while advancing to facilitate passage of the tube through the pylorus and into the jejunum.

5. Advance the tube until the tip of the tube is 1015 cm beyond the Ligament of Treitz and the balloon is in the stomach.

6. Ensure the external bolster is flush with the skin.

7. Using a Luer slip syringe, inflate the balloon.

Inflate the balloon with 35 ml of sterile or distilled water for pediatric sized tubes (REF numbers ending in -15 -22 or -30)

Caution: Do not exceed 5 ml total balloon volume. Do not use air. Do not inject contrast into the balloon.

Inflate the balloon with 710 ml of sterile or distilled water for adult sized tubes (REF numbers ending in -45).

Caution: Do not exceed 10 ml total balloon volume. Do not use air. Do not inject contrast into the balloon.

8. Remove the guidewire through the introducer cannula while holding the cannula in position. Remove the introducer cannula.

Daily Care & Maintenance Checklist of MIC-KEY Gastric-Jejunal Feeding Tube

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, 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 cottontipped 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 23mm above the skin.

Flush the feeding tube

Flush the feeding tube with water using a catheter tip or slip tip syringe every 46 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

MIC-KEY Gastric-Jejunal Feeding Tube Balloon Maintenance

Check the water volume in the balloon once a week.

Insert a slip tip 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 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 1020 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.

MRI Safety Information of Avanos MIC-KEY Jejunal Feeding Tube

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.
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of < 2 W/kg (Normal Operating Mode)

Avanos 0270-16-4.0-45 MIC-KEY Gastric-Jejunal Feeding Tube Device Characteristics