C.R. Bard FOL0101 - StatLock Foley Stabilization Device, Foam Anchor Pad w/Perspiration Holes, for Latex Catheter, Adult, 25/CS

C.R. Bard FOL0101 - StatLock Foley Stabilization Device, Foam Anchor Pad w/Perspiration Holes, for Latex Catheter, Adult, 25/CS

C.R. Bard FOL0101 StatLock Foley Stabilization Device

StatLock Stabilization Devices are a more effective alternative to tape in helping improve clinical outcomes, quality of care and economic efficiency. The StatLock Foley stabilization device accommodates latex 8-22 Fr. and silicone 8-26 Fr. catheters for the ultimate in versatility. Available in adult and pediatric sizes.

C.R. Bard FOL0101 StatLock Foley Stabilization DeviceFeatures and Benefits

• Reduce Foley catheter movement
• Minimize accidental catheter dislodgements
• Maximize patient comfort by:
• Eliminating circumferential compression
• Alleviating traction of urethral catheters
• The StatLock Foley Stabilization Device sets new, worldwide standard for Foley catheter stabilization.
• Featuring a patented swivel retainer for enhanced patient comfort and convenience.
• Available in adult and pediatric sizes for most latex and silicone catheters.
• Releasable, lock-tight securement.

StatLock Device Retainer Design

• Lock-tight design stabilizes catheter to prevent pistoning and accidental dislodgement.
• Swivel design allows catheter movement with the patient without exerting a pull force on the catheter.
• Releasable design allows for easy cleaning of patient.
• Accommodates both 2-way and 3-way latex 822 Fr. and silicone 626 Fr. catheters for the ultimate in versatility.

StatLock Device Anchor Pad Design

• Available in breathable latex-free tricot fabric for added patient comfort.
• Available in both pediatric and adult sizes, giving you the versatility needed for effective Foley catheter stabilization.
• Designed to be easier to use than tape and circumferential leg straps.
• Unique alcohol-soluble adhesive is gentle on the skin.

C.R. Bard FOL0101 StatLock Foley Stabilization Device Indications for Use

The StatLock device is a stabilization device for compatible catheters.

Warnings and Precautions of C.R. Bard FOL0101 StatLock Foley Stabilization Device

• Do not use the StatLock device where loss of adherence could occur, such as with a confused patient, diaphoretic or non-adherent skin, or when the access device is not monitored daily.
• Observe universal blood and body fluid precautions and infection control procedures, during application and removal of the StatLock device.
• Minimize catheter manipulation during application and removal of the

C.R. Bard FOL0101 StatLock Foley Stabilization Device Application Technique

Prep

• 1.Place Foley catheter into retainer. Directional arrow should point towards catheter tip, and balloon inflation arm should be next to the clamp hinge.
• 2. Close lid, being careful to avoid pinching the catheter.
• 3. Identify securement site by laying the device retainer on the front of the thigh, leaving 1 inch of catheter slack between insertion site and the StatLock device retainer.
• 4. After placing the StatLock Stabilization device off to the side, cleanse and degrease the securement site with alcohol per hospital policy. Let skin dry.
• 5. Apply skin protectant, in direction of hair growth, to area larger than securement site. Allow to dry completely (10-15 seconds).
• 6. Using permanent marker, write initials and date of application on the StatLock device anchor pad.

NOTE: Always secure catheter into the StatLock device retainer before applying adhesive pad on skin.

Place and Peel

• 7. Align the StatLock Stabilization Device over securement site leaving 1 inch of catheter slack. Make sure leg is fully extended.
• 8. While holding the retainer to keep the pad in place, peel away paper backing, one side at a time and place tension-free on skin.

Daily Maintenance

• The StatLock device should be assessed daily and changed when clinically indicated, at least every seven days.
• If pad becomes soiled, wash with soap/water, saline or hydrogen peroxide. 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

Removal Technique

Disengage

• 1. Open retainer by pressing release button with thumb, then lift to open.
• 2. Remove Foley catheter from the StatLock device.

Dissolve

• 3. Wipe the edge of the pad using at least 5-6 alcohol pads until a corner lifts. Then continue to stroke undersurface of pad with alcohol to dissolve adhesive pad away from skin.

Do not pull or force pad to remove.

Device Characteristics of C.R. Bard FOL0101 StatLock Foley Stabilization Device

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No