Cook Medical COKG13722 - Emergency Pnemothorax Set 6cm 8.5Fr Ea

Cook Medical COKG13722 - Emergency Pnemothorax Set 6cm 8.5Fr Ea

Cook Emergency Pneumothorax Set

Used for Emergency Relief and Temporary Management of Suspected Tension Pneumothorax

The Standard Cook Emergency Pneumothorax Set consists of:

• Catheter introducer-needle
• Cook Chest Drain Valve
• Connecting tube
• 12 ml syringe
• Molnar disc
• One-way stopcock
• Tinted ChloraPrep
• Transparent tape
• Alcochol prep

Intended for emergency relief and temporary management of suspected tension pneumothorax. Because tracheal deviation and jugular venous distention may not always be identified, a tension pneumothorax should be supspected when the following three criteria are identified:

1. Increasing respiratory distress or difficulty ventilating a patient with a bag-valve-mask device.
2. Markedly decreased or absent breath sounds on the ipsilateral side.
3. Hemodynamic compromise (decompensated shock) manifested by hypotension and/or evidence of diminished perfusion.

Features & Benefits

• Catheter-over-needle placement facilitates controlled, minimally invasive catheter introduction.
• Reinforced catheter prevents collapse.

Contraindications

• Not recommended for simple pneumothorax or hemothorax.

Warnings

• Improper diagnosis and use of this device may lead to the creation of a simple or tension pneumothorax.
• Improper placement may result in life-threatening injury to the heart, great vessels in the mediastinum or damage to the lung.
• Bilateral needle decompression of the pleural spaces should be performed only on patients who are receiving positive pressure ventilation. Bilateral pleural decompression in the spontaneously breathing patient may result in significant respiratory compromise.

Precautions

• This product is intended for use by physicians trained and experienced in the treatment of a pneumothorax. Standard techniques for placement of pneumothorax catheters should be employed.
• Use standard precautions for body substance isolation.
• Lung puncture may result in an air embolus, which could lead to ischemia or infarction of major organs, including the brain or cardiac system.
• The potential effects of phthalates on pregnant/nursing women or children have not been fully characterized and there may be concern for reproductive and developmental effects.

Instructions for Use

1. Connect the syringe to the catheter introducer-needle.
2. Prep the access site using standard hospital protocol.
   NOTE: The optimal insertion site for the catheter introducer-needle is in the second or third intercostal space in the mid-clavicular line. The second intercostal space is inferior to the second rib, which articulates with the sternum at the angle of Louis.
3. Insert the catheter introducer-needle into the skin along the superior border of either the third or fourth rib. Advance the device through the skin, subcutaneous tissue, muscle and parietal pleura with one hand while gently pulling suction in the syringe with the other hand.
4. Once air is freely aspirated into the syringe, the needle should not be advanced any further. Stabilize the needle and syringe with one hand and slowly advance the catheter into the pleural space with the other hand. If any resistance is encountered, the catheter should not be forced.
5. Once the catheter is inserted into the pleural space, the needle and syringe are withdrawn, leaving the catheter in place.
6. If included, the plastic skin flange can be placed around the catheter and secured using the self-locking tie. This flange provides a convenient place to secure the catheter to the skin using adhesive tape.
7. Breath sounds and hemodynamic status should be reevaluated after inserting and securing the device.
8. Stopcock, connecting tubing and Cook Chest Drain Valve may be attached if included in the set.

How Supplied

Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure to light. Upon removal from package, inspect the product to ensure no damage has occurred.