MIC-KEY Low Profile Jejunal Feeding Tube is recommended for patients who cannot absorb adequate nutrition through the stomach, have intestinal motility issues, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or have had a previous esophagectomy or gastrectomy. The MIC-KEY Low-Profile Jejunal Feeding Tube can be inserted percutaneously under fluoroscopic or endoscopic guidance, or as a replacement for an existing device with an established stoma tract.

Features

• Tapered distal tip.
• Low-profile design.
• Radiopaque stripes.
• With EnFit connections.
• Gastric decompression port.
• Medical-grade silicone structure.
• Silicone internal retention balloon.
• Radiopaque weighted jejunal part.
• Multiple gastric and jejunal exit ports.
• SECUR-LOK extension set connection mechanism.
• The external bolster is built like the commonly recommended MIC-KEY gastrostomy tube.
• Suitable for patients who solely require jejunal feeding and prefer a discreet external section.

Indications For Use

AVANOS MIC-KEY Low-Profile Jejunal Feeding Tube is recommended for use in people who cannot absorb appropriate nourishment through the stomach. Those with intestinal motility issues, gastric outlet blockage, and significant Those who have gastric reflux are at risk of aspiration, or have prior esophageal or gastrectomy.

Contraindications

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

Complications

The following complications may be associated with any transgastric jejunal feeding tube:

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

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

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

Placement

The Avanos MIC-KEY Low-Profile 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.

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 may be adjusted using a razor blade or scalpel. Ensure that the cut is smooth and blunt, and the length is sufficient. It 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.

Balloon Maintenance

• 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 that as you deflate the balloon, some gastric contents may leak 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 overinflation can obstruct the lumen or shorten balloon life, and underinflation will not properly secure the tube.

Check the water volume in the balloon once a week.

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 that 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) of < 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.

Warning: For enteral nutrition and/or medication only.

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.

Model No:	Diameter (Fr)	Jejunal Length (cm)	Silicone Internal Retention Balloon Volume (ml)	Stoma Length (cm)
8230-14-0.8	14	82	5	0.8
8230-14-1.0	14	82	5	1.0
8230-14-1.2	14	82	5	1.2
8230-14-1.5	14	82	5	1.5
8230-14-1.7	14	82	5	1.7
8230-14-2.0	14	82	5	2.0
8230-14-2.3	14	82	5	2.3
8230-14-2.5	14	82	5	2.5
8230-14-2.7	14	82	5	2.7
8230-14-3.0	14	82	5	3.0
8230-14-3.5	14	82	5	3.5
8230-14-4.0	14	82	5	4.0
8230-14-4.5	14	82	5	4.5
8230-18-0.8	18	82	5	0.8
8230-18-1.0	18	82	5	1.0
8230-18-1.2	18	82	5	1.2
8230-18-1.5	18	82	5	1.5
8230-18-1.7	18	82	5	1.7
8230-18-2.0	18	82	5	2.0
8230-18-2.3	18	82	5	2.3
8230-18-2.5	18	82	5	2.5
8230-18-2.7	18	82	5	2.7
8230-18-3.0	18	82	5	3.0
8230-18-3.5	18	82	5	3.5
8230-18-4.0	18	82	5	4.0
8230-18-4.5	18	82	5	4.5