Bard Bardex Two-Way Infection Control Foley Catheter with 3cc Balloon Capacity

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• Cautions:
  - Federal (U.S.A.) law restricts this device to sale by or on the order of a physician
  - Do not aspirate urine through drainage funnel wall.
  - Some Foley catheters may contain Natural Rubber Latex which may cause allergic reactions.
  - Please check package.
  - Contains or Presence of Phthalates: Di(2-ethylhexyl)phthalate (DEHP) is a plasticizer used in some polyvinyl chloride medical devices.
  - DEHP has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy.
  - Although the toxic and carcinogenic effects of DEHP have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial.
  - There is no evidence that neonates, infants, pregnant and breast feeding women exposed to DEHP experience any related adverse effects. However, a lack of evidence of causation between DEHP-PVC and any disease or adverse effect does not mean that there are no risks.
  - With Temperature-Sensing Probes, in the presence of RF energy sources, local heating, temperature errors, and probe damage may occur.
  - In medical use, unplug the temperature-sensing catheter at the temperature monitor before activating electrosurgical or other types of direct coupled RF energy sources.
  - Do not stretch catheter. This will cause repositioning of the probe.
  - Do not use Stylet. This will cause stretching of catheter.
• WARNINGS:
  - On catheter, do not use ointments or lubricants having a petrolatum base. They will damage latex 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.
  - Visually inspect the product for any imperfections or surface deterioration prior to use. Use Luer tip syringe to inflate with stated mL of sterile water OR for pre-filled products, remove clip and squeeze reservoir to inflate with stated mL of sterile water.
  - Store catheters at room temperature away from direct exposure to light, preferably in the original box.
• ADDITIONAL INFORMATION:
  - 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 patient.
  - Aggressive traction, particularly in the presence of suturing is not recommended for 100% silicone catheters.
  - Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.
  - Do not exceed recommended balloon capacities
  - Sterile unless package is opened or damaged.
  - Catheters should be replaced in accordance with the CDC guideline, "Guideline for Prevention of Catheter-Associated Urinary Tract Infection." At the onset or first signs of a urinary tract infection, catheter encrustation, or any other catheter-related adverse effect, the catheter should be replaced.
• DAILY MAINTENANCE:
  - Do not use alcohol or prepackaged bathing systems, which could lead to early lifting. If showering/bathing, cover with plastic wrap or waterproof dressing.
  - Conduct skin assessment prior to application and repeat daily per facility protocol.
  - Use clinical judgment on the removal of the STATLOCK® stabilization device if the patient experiences any fluid shifts that may interfere with skin integrity. - Sterile unless package is opened or damaged.
• Indications for Use:
  - The Bardex® I.C. Latex Foley Catheter is indicated foruse 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. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.
• Directions for Use:
  1. 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.
  2. Using proper aseptic methods, remove catheter from package.
  3. Prepare patient per hospital/nursing recommended procedure.
  4. Proceed with catheterization using standard techniques.
  5. Inflate the balloon with sterile water to the volume stated on the inflation lumen of the catheter by using a water-filled Luer tip syringe.
  6. Connect catheter tocollection container.
  7. To deflate the balloon, gently reinsert the Luer tip syringe into the valve and aspirate.