Flexi-Seal PROTECT Fecal Management System by Convatec

Flexi-Seal PROTECT Fecal Management System (FMS) is a clinically proven solution for managing fecal incontinence by safely containing liquid to semi-liquid stool and minimizing exposure risks. This soft silicone catheter system features the PROTECT over-inflation indicator and a patented blue finger pocket for easy, accurate balloon placement. Ideal for medication administration and infection control, it also includes a privacy collection bag with a high-performance APS filter to capture odors and eliminate manual gas release.

Features:

• PROTECT Indicator: Visual warning system prevents balloon over-inflation.
• Blue Finger Pocket: Ensures accurate and easy placement of retention balloon.
• Medication Access: Allows for safe and direct rectal administration of treatments.
• Full-Length Odor Barrier: Silicone catheter design minimizes odor from end to end.
• Blue Sampling Port: Enables safe, hygienic stool collection with reduced exposure risk.
• Enhanced Privacy Collection Bag: APS filter captures 6x more odor than charcoal bags.
• C. difficile Containment: In vitro proven to contain the pathogen and limit its environmental spread.

Kit Contains:

• 1 Soft catheter tube assembly
• 1 Luer-Lock Syringe
• 1 Collection bag with filter
• 1 cinch clamp

Contraindications:

This product is not intended for use:

• For more than 29 consecutive days
• For pediatric patients (patients under 18 years of age) as its use has not been tested in this population

The Flexi-Seal PROTECT Fecal Management System should not be used on individuals who:

• Have suspected or confirmed rectal mucosal impairment, i.e. severe proctitis, ischemic proctitis, mucosal ulcerations
• Have had rectal surgery within the last year
• Have any rectal or anal injury
• Have hemorrhoids of significant size and/or symptoms
• Have a rectal or anal stricture or stenosis
• Have a suspected or confirmed rectal/anal tumor
• Have any in-dwelling rectal or anal device (e.g. thermometer) or delivery mechanism (e.g. suppositories or enemas) in place
• Are sensitive to or who have had an allergic reaction to any component within the system

Warnings:

• Clinicians should be aware that there are very limited clinical data on the use of in-dwelling fecal management systems after 14 days continued use.
• There is a potential risk of misconnections with connectors from other healthcare applications, such as intravenous equipment, breathing and driving gas systems, urethral/urinary, limb cuff inflation neuraxial devices and other enteral and gastric applications.
• Not following these instructions for use may increase the likelihood of an adverse event.
• Patients should be monitored daily for and a physician notified immediately if any of the following occur:
  • Rectal pain
  • Rectal bleeding
  • Abdominal symptoms such as distension/pain
• Over inflation of the retention balloon has the potential to increase the risk of adverse events including rectal pain, bleeding, ulcerations, and possible perforations.
• There is a danger of fecal obstructions with this product.

General Guidelines:

• The device may be changed as needed to perform normal patient assessment.
• The device is not intended for use for more than 29 consecutive days.
• If the product packaging or content are visibly damaged, do not use.
• For more detailed instructions refer to the Directions for Use provided in the device package.

Directions for Use:

Preparation of Device & Patient:

• In addition to the device kit, gloves, lubricant and water or saline will be required.
• Using the syringe provided, remove the air that is in the balloon by attaching the syringe to the white inflation port (marked “≤45ml”) and withdraw the plunger.
• Remove the supplied syringe and fill it with only 45ml of water or saline and connect the syringe to the white inflation port of the catheter.
• Securely attach the collection bag to the connector at the end of the catheter. The small hook on the catheter is designed to help secure connection from the bag to the connector.
• Use your labels to write insertion date and time. Place on the allocated space at the end of bead strap.
• Position the patient in left side-lying position; if unable to tolerate, position the patient so access to the rectum is possible.
• Perform a digital rectal exam to evaluate suitability for insertion of device.
• The rectum should have adequate anal tone and be free of solid stool or any in-dwelling or anal device prior to insertion

Insertion of Device:

• Unfold the length of the catheter to lay it flat on the bed, extending the collection bag toward the foot of the bed.
• Insert a lubricated gloved finger into the blue finger pocket for digital guidance during device insertion (the finger pocket is located above the position indicator line).
• Coat the balloon end of the catheter with lubricant.
• Grasp the catheter and gently insert the balloon end through the anal sphincter until the balloon is beyond the external orifice and well inside the rectal vault.
• The finger may be removed or remain in place in the rectum during initial balloon inflation.
• Begin inflating with water or saline by slowly depressing the syringe plunger.
• Never inflate the retention balloon with more than 45ml.
• With the insertion finger removed, the green dome will indicate once the balloon has reached the optimal fill level for the anatomy.
• Stop inflation once the green dome has signalled optimal fill.
• Under no circumstances should the balloon be inflated with more than 45ml of fluid.
• If the PROTECT dome indicates at less than 30ml of fluid, withdraw the fluid and reposition the balloon in the rectal vault.
• After repositioning, fill the balloon as described above.
• DO NOT fill with more than 45ml of fluid.
• The red PROTECT indication dome will start to indicate if the balloon is overfilled beyond the maximum 45ml of fluid.
• If the red PROTECT indication dome is fully inflated, assess patient’s position, fully deflate the balloon and repeat the balloon inflation process.
• Stop inflation once green dome has signalled optimal fill.
• Remove the syringe from the inflation port, and gently pull on the soft catheter to check that the balloon is secure in the rectum and that it is positioned against the rectal floor.
• Take note of the position indicator line relative to the patient’s anus.
• Regularly observe changes in the location of the position indicator line as a means to determine movement of the retention balloon in the patient’s rectum.
• This may indicate the need for the balloon or device to be repositioned.
• In the event of expulsion of the device, deflate the balloon fully; rinse the balloon end of the catheter and reinsert following the instructions for ‘Insertion of Device’.
• A rectal exam should be conducted prior to reinsertion to verify that no stool is present.
• If expulsion continues for more than three episodes discontinuation of the device should be considered.
• Position the length of the flexible catheter along patient’s leg avoiding kinks and obstruction.
• Hang the bag by the bead strap on the bedside at a position lower than that of the patient.

Irrigation, Maintenance & Removal of Device:

• To irrigate the device, fill the syringe with water at room temperature, attach the syringe to the BLUE irrigation/medication port (marked “IRRIG./Rx”) and slowly depress the plunger.
• Clinicians should take extra care to use the blue irrigation/medication port only when irrigating.
• DO NOT irrigate through the white inflation port (marked “≤45ml”) as this would lead to over inflation of the retention balloon and the device would not be irrigated as intended.
• If repeated flushing with water does not return the flow of stool through the catheter, the device should be inspected to ascertain that there is no external obstruction (i.e. pressure from a body part, piece of equipment, or resolution of diarrhea).
• If no source of obstruction of the device is detected, use of the device should be discontinued.
• Change collection bag as needed.
• Discard used bags according to institutional protocol for disposal of medical waste.
• Observe the device frequently for obstructions from kinks, solid fecal particles or external pressure.
• To remove the catheter from the rectum, the retention balloon must first be deflated.
• Attach the syringe to the white inflation port (marked “≤45ml”) and slowly withdraw all fluid from the retention balloon.
• Disconnect the syringe and discard.
• Grasp the catheter as close to the patient as possible and slowly remove from the anus.
• Dispose of device in accordance with institutional protocol for disposal of medical waste.