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BARDEX I.C. Foley Catheter

BARDEX I.C. Foley Catheter

BARDEX I.C.

Medical device
  • CE Marked medical device (Class IIa/IIb, depending on configuration) for urinary catheterisation within applicable EU/UK medical device regulations.
  • Registered with and regulated by the MHRA for supply in the UK as a urological medical device.
  • Manufactured under ISO 13485 Certified quality management systems for medical devices by BD (Bard).
  • Designed and marketed in line with CDC and international guidelines for prevention of catheter Associated urinary tract infections (CAUTIs), including recommendations for using antimicrobial Coated catheters in selected high Risk patients.
Anti-infective indwelling Foley urinary catheter

Description

The BARDEX I.C. Foley Catheter is an anti-infective latex indwelling urinary catheter designed to reduce catheter-associated urinary tract infections (CAUTIs). It incorporates a technologically advanced formulation that combines BD (BARD) hydrogel with a BACTI-GUARD/Bactiguard silver alloy coating applied to the inner and outer catheter surfaces. This dual coating dramatically reduces bacterial adherence and minimises biofilm formation along the catheter. Clinical data show that the occurrence of urinary tract infection is approximately 3.7 times greater in patients catheterised with a standard catheter than in those catheterised with the BARDEX I.C. Foley catheter with hydrogel and silver alloy coating. The device is intended for transurethral or suprapubic urinary drainage, collection and measurement and is typically indicated for indwelling use for up to 28 days, depending on clinical judgement and local guidelines.

Bnefits

  • Clinically proven reduction in catheter-associated urinary tract infections compared with standard Foley catheters.
  • Hydrogel and silver alloy anti-infective coating reduces bacterial adherence to the catheter surface.
  • Minimises biofilm formation on both the inner and outer catheter surfaces.
  • Inhibits migration of pathogenic organisms into the bladder along the catheter.
  • Hydrogel coating helps preserve the integrity of the urethral mucosa and may improve patient comfort at insertion and during indwelling use.
  • Can remain in situ for up to 28 days as recommended by the manufacturer, subject to clinical assessment.
  • Available in a range of French sizes, balloon volumes and configurations (2-way and specialty 3-way) to suit different clinical needs.

Indications

  • Indwelling transurethral or suprapubic urinary bladder drainage, collection and/or measurement of urine.
  • Use in patients who require catheterisation for management of urinary retention, incontinence, perioperative bladder drainage, monitoring of urinary output or other standard Foley catheter indications.
  • Intended to reduce the risk of catheter-associated urinary tract infections in patients who require an indwelling urinary catheter.

Composition

  • Catheter shaft material: latex (natural rubber) with hydrogel and silver alloy anti-infective coating (standard BARDEX I.C. latex models).
  • Coating: BARD/BD hydrogel applied to internal and external surfaces for lubrication and mucosal protection.
  • Coating: BACTI-GUARD/Bactiguard silver alloy antimicrobial coating applied to internal and external surfaces to reduce bacterial adherence and biofilm formation.
  • Balloon: latex balloon (volume typically 5–10 mL for 2-way and up to 30 mL for some models), filled with sterile water per instructions for use.
  • Some specialty variants are all-silicone or latex-free, but the core BARDEX I.C. product described is a silver alloy–coated latex Foley catheter.

Formulation

  • Device type: Indwelling Foley urinary catheter, usually 2-way (drainage lumen plus balloon inflation lumen); 3-way variants with irrigation lumen also available.
  • Hydrogel/silver alloy coating applied to both the inner and outer catheter surfaces for anti-infective and lubricious properties.
  • Size range: commonly available in 12–24 Fr (French) sizes, with balloon capacities e.g. 5 mL, 10 mL or 30 mL depending on model.
  • Tip style: standard (straight) Foley tip; some variations include coude/Tiemann or specialty tips according to product code.
  • Length: adult catheters typically around 35–50 cm (approximately 40–43 cm) depending on the specific model.

Packaging

  • Individually sterile-packed, single-use catheter in peel-open blister or pouch.
  • Each pack includes one sterile catheter with pre-labelled size (Fr), balloon volume, material and coating details.
  • Usually supplied in boxes of multiple units (e.g. box of 10 or 12 catheters) for hospital and clinical use; retail units may be sold individually.
  • Labelling includes instructions for use, indication of latex content, silver alloy/hydrogel coating and maximum recommended indwelling time (up to 28 days).

Usage

  • Use only by trained healthcare professionals following local catheterisation protocols and aseptic technique.
  • Prepare and position the patient according to hospital/nursing guidelines for catheter insertion.
  • Open the sterile pack and handle the catheter using aseptic technique; lubricate as required (the hydrogel coating becomes lubricious when moistened).
  • Gently insert the catheter transurethrally (or via suprapubic tract as indicated) into the bladder until urine flows, then advance slightly further per institutional protocol.
  • Inflate the retention balloon with the recommended volume of sterile water (e.g. 5–10 mL or 30 mL depending on the catheter model and balloon size stated on the catheter hub/pack).
  • Confirm correct placement by ensuring free urinary drainage into the collection system; secure the catheter to the patient per local policy to minimise traction and urethral trauma.
  • Connect to a sterile closed urinary drainage system and maintain a closed circuit to reduce infection risk.
  • Monitor urine output, catheter function and patient comfort; inspect for signs of blockage, leakage, infection or encrustation.
  • Recommended indwelling time not to exceed 28 days; remove or change earlier if clinically indicated (e.g. obstruction, infection, encrustation, or per local CAUTI-prevention policies).
  • On removal, fully deflate the balloon using a syringe attached to the inflation valve before gently withdrawing the catheter.
  • Dispose of the catheter as clinical waste in accordance with local infection control and sharps/contaminated materials policies.

Contraindications

  • Known hypersensitivity or allergy to latex (natural rubber), as standard BARDEX I.C. catheters are latex-based.
  • Known hypersensitivity or allergy to silver or silver alloy components of the coating.
  • Patients in whom urethral catheterisation is contraindicated (e.g. suspected urethral injury, certain urethral strictures or trauma) unless a suprapubic route is used per specialist advice.
  • Use beyond the recommended indwelling time (up to 28 days) without appropriate clinical review.
  • Use in patients where a non-latex or all-silicone catheter is specifically required (e.g. severe latex sensitivity, long-term catheterisation where silicone is preferred).

Adverse Effects

  • As with all indwelling urinary catheters, potential for catheter-associated urinary tract infection, although the BARDEX I.C. design is intended to reduce this risk.
  • Local urethral trauma, discomfort or bleeding during insertion or removal if technique is suboptimal.
  • Bladder spasms, discomfort or suprapubic pain related to the presence of an indwelling catheter or balloon.
  • Urethral irritation or inflammation; long-term use may increase the risk of urethral strictures or erosions.
  • Potential allergic reactions in patients sensitive to latex or silver, including local irritation, rash or, rarely, systemic hypersensitivity.
  • Encrustation and blockage of the catheter lumen, particularly in patients with alkaline urine, infection or long dwell times, although anti-infective coating aims to reduce biofilm-related encrustation.
  • Leakage around the catheter (bypassing) if the catheter becomes blocked, mis-sized, or if bladder spasms occur.

Storage Conditions

  • Store in a clean, dry environment at room temperature, away from excessive heat, moisture and direct sunlight.
  • Keep in original packaging until use to maintain sterility.
  • Do not use if the packaging is damaged, opened or compromised, or if the expiry date on the pack has passed.
  • Do not attempt to resterilise or reuse; the catheter is single-use only.

Duration

Intended for short- to medium-term indwelling urinary catheterisation with a recommended maximum dwell time of up to 28 days, subject to clinical judgement and local protocols. Catheter change or removal should occur earlier if indicated by the patient\u2019s condition or institutional CAUTI-prevention guidelines.

Onset

Immediate upon successful placement and balloon inflation: urine drainage begins once the catheter tip is in the bladder. Anti-infective benefit in terms of reduced bacterial adherence and biofilm formation is continuous over the indwelling period as long as the hydrogel and silver alloy coating remains intact.

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