Bardia Foley Catheter (Silicone Elastomer Coated, 2-Way)

Product Description :

Bardia Silicone Elastomer Coated Foley Catheter 30mL Balloon (Two-Way)

Bardia Foley Catheter 2-Way is a latex foley catheter (urological catheter) with a silicone-elastomer coating and two distinct lumens. Available in 30mL/cc balloon sizes. 12-30Fr

The Bardia 2‑Way Foley Catheter consists of two ports—a urine drainage port for attachment to a collection bag, and a color‑coded balloon‑inflation port labeled with the recommended volume and french size (Fr/Ch) or millimeter (mm) dimensions. Once sterile water is introduced through the balloon port, the balloon inflates to secure the catheter in place and enhance retention. The catheter also includes lateral eyes near the bladder opening to ensure efficient urine drainage.

The Bardia Foley Catheter is a sterile, single-use medical device intended for urological use only. It is sterilized by radiation.

The clinical benefits of Bardia Silicone Elastomer Coated Foley Catheters are that they aid in a clinical management by allowing for continuous drainage and measurement of urine, and when applicable, bladder irrigation and hemostasis.

Foley catheters can be used in patients of all ages. Up to 10 CH/Fr is generally considered pediatric sizing; however, the appropriate size should be determined by the healthcare professional.

Indications for Use: The Bardia Silicone Elastomer Coated Foley Catheter is indicated for use in the drainage and/or collection and/or measurement of urine.

Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.

Intended User: This product is intended to be used by qualified Healthcare Professionals.

Intended Use: For urological use only.

Contraindication: No known contraindications.

Warnings:

• On catheter, do not use ointments or lubricants having a petroleum base. They will damage catheter and may cause balloon to burst.

• After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.

• This is a single use device. Do not resterilize any portion of this device. Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness, or death of the patient.

Precautions:

• Do not use device if package is opened or damaged.

• Do not aspirate urine through drainage funnel wall.

• Should balloon rupture occur, care should be taken to assure that all balloon
fragments have been removed from the patient.

Cautions: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

Storage: Keep away from sunlight.

Instructions for Use:

1. Follow your facility protocol for all processes related to catheterisation, re-catheterisation, stabilization and urine collection.
2. Follow aseptic procedures outlined by your local hospital or healthcare facility. Thoroughly wash hands, wear sterile gloves, and use aseptic technique whenever handling the catheter or catheter components during insertion.
3. Visually inspect the product for any imperfections or surface deterioration prior to use.

If package is opened or if any imperfection or surface deterioration is observed, do not use.

Insertion:

(1) Wash hands.

(2) Use aseptic technique to prepare the patient for catheter insertion.

(3) Use aseptic technique to remove the catheter from package. Connect catheter to urine collection container as needed.

(4) Lubricate the catheter. If hospital policy permits, it is possible to inject lubricant into the urethra.

(5) Catheterize the patient using dominant hand.

(6) When catheter tip has entered bladder, urine will flow through the catheter.
a. For female anatomy, insert catheter approximately 5 cm (2 inches) more.
b. For male anatomy, insert catheter all the way to bifurcation.

(7) Inflate the balloon with pre-filled water syringe if included. For pre-filled products, remove clip and squeeze reservoir to inflate with stated mL/cc of sterile water.
a. If pre-filled syringe is not included, then use a slip tip/luer lock syringe to fill catheter balloon with sterile water. Do not use needle.
b. Do not exceed recommended capacities as stated on the applicable labelling.
c. The chart below provides additional information on inflation volume and balloon size.
d. Inflation Volume (A) incorporates the volume required to pass through lumen and fully inflate the specific Balloon Size (B).

Note: Drawing may not display actual shape of catheter tip or presence of additional lumen(s).

(8) Gently pull the catheter until the catheter balloon is snug against the bladder neck.

Recommended Inflation Capacities:
5mL/cc Balloon: use 10mL/cc sterile water
30mL/cc Balloon: use 35mL/cc sterile water
Do not exceed recommended capacities. 

Removal:

(1) Wash hands.

(2) Gently insert a luer slip tip syringe into the catheter valve.

a. Never use more force than is required to make the syringe “stick” in the valve.

(3) Allow the pressure within the balloon to force the plunger back and fill the syringe.
a. If you notice slow or no deflation, re-seat the syringe gently.

(4) Use only gentle aspiration to encourage deflation, if needed. Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.

(5) If balloon does not deflate, contact trained professional for assistance, as directed by hospital protocol.

(6) After balloon is fully deflated, remove catheter, and dispose of in accordance with hospital policy.

Features & Specifications :

• Reference, Size and Color:

1. 123614CE 14Ch/Fr 4.7mm (Green),
2. 123616CE 16Ch/Fr 5.3mm (Orange),
3. 123618CE 18Ch/Fr 6.0mm (Red),
4. 123620CE 20Ch/Fr (Yellow)

• 2-Way Foley Catheter contains a urine drainage port and a balloon‑inflation port

• 30 cc/mL Balloon with 35 cc/mL inflation volume capacity

• Long drainage tube/pipe for proper urine flow

• Lateral eyes near the tip (bladder opening)

• Can be used for both male and female

• Sterilized by radiation

• Single use

• Contains or presence of natural rubber latex

• Bard urological catheter

• Color coded valve for instant size identification

• Sterile and individually packed in peelable, soft blister pack

Package Contents :

1. Bard Bardia Foley Catheter - One Unit (Individual Pack)

More Information: The box contains 10 units