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Catalog Number 190011
Device Problems Leak/Splash (1354); Torn Material (3024)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Event Description
It was reported that the fecal containment device tore when the patient was moved, and the device allegedly leaked.
Manufacturer Narrative
The device was not returned for evaluation. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: "kit contains the following: latex collection bag with applicator, adhesive remover, closure clip, powder adhesive, drainage bag adaptor, soap, liquid adhesive with swab. The bard® fcd¿ device provides a safe and effective method for managing fecal incontinence. This kit can be used to manage all consistencies of stool, ranging from firm to liquid stools. Causes of fecal incontinence: antibiotic therapy often has the side effect of copious diarrhea. Induced feeding, either nasogastric or hyperalimentation may lead to diarrhea. Patients experiencing a decreased neurological status, such as stroke and alzheimer¿s disease. Caution: this product contains natural rubber latex which may cause allergic reactions. Cautions: check the patient¿s bowel status frequently. Reassess the patient¿s bag and anus patency at least every 2 hours. Evidence of stool or flatus should appear in the collection bag. If not, reassess the patient¿s bowel status and bag placement. Notify the physician if the condition continues. If redness or irritation is noticeable, remove the device and adhesive from the patient and consult a physician. Avoid rolling the bag and putting it into a diaper or into pants. Allow the bag to hang freely; the bag may hang through the pant leg or leg opening in the diaper. Empty the bag before ambulating the patient. Do not use ointments having a petroleum base, as they will damage the latex device. Caution: liquid adhesive is flammable. Keep away from fire, sparks and heated surfaces. Features of the fcd¿ product: to the patient, the main concerns are comfort and dignity. The bard® fcd¿ product is applied with a gentle adhesive to the anal area. This is the same adhesive used to adhere artificial prostheses (noses, ears, etc. ), thus it is strong enough to ensure secure placement of the device. The adhesive is gentle enough to be used on a daily basis. In addition to this liquid adhesive, a powder adhesive is used as a drying agent. Because the fcd¿ product features a very thin wall of latex in the application area, it moves with the patient¿s body during bowel movements. For this reason, there is no fear of painful use or of disconnecting the device during bowel movement. The lubricated interior of the pouch helps slide stool away from the anal opening quickly, further lessening contact with patient skin. Perhaps the most appealing feature of the product, however, is that it can be worn discreetly allowing the patient to remain ambulatory while it is in place. Store at room temperature and away from direct sunlight. Troubleshooting tips: when wear times are less than 24 hours, the problems can usually be traced to one of the following: use of soaps or solutions containing emollients or lanolin for cleaning. Less than thorough cleaning and drying of the patient. Contamination of the adhesive surfaces. Insufficient pressure exerted during the application. Insufficient attention to potential leak sites on the patient. Not emptying the device regularly to avoid a continuous tug on the seal. Expecting too much initial performance for an excoriated patient. Objectionable odor: if leakage occurs at the bag/patient seal, the device is ready to be replaced. If the bag/patient seal is intact, you will most likely find that the inside of the bag tail, below the clip is damp or wet. Either this area was not dried thoroughly after emptying the bag, or the clip is not secured tight enough to stop seepage. Dry the inside of the tail and secure the clip. If the problem persists and seepage continues, a strip of tape over the end of the tail should solve this problem. If the tail of the bag is dry with no signs of seepage, and the bag is hooked up to dependent drainage, check the seal at the adaptor fitting for signs of leakage. If seepage is occurring here, a strip of tape should solve the problem. If there is no leakage, consider the dependent drainage vent. 1. Check contents of kit remove collection bag from kit. Check to ensure the position of the applicator is centered in the small opening of the collection bag. 2. Applying liquid adhesive remove liquid adhesive and swab from kit. Open liquid adhesive. Generously apply 1/3 of liquid adhesive to the bag area around the small opening. Adhesive is to extend down all sides of the ¿cap¿ or ¿top¿ of the applicator. Pay particular attention that adhesive is applied to the high points and to the sides of the applicator. Replace the cap on the vial. 3. Position patient from this point on, buttocks must remain apart until application of device. Clean patient thoroughly cleanse the area around the anus (perianal area) with water and the bar soap provided in your kit. Rinse thoroughly with water. Dry area well. Remember: any agents left on the skin, or use of a lanolin-containing soap, will shorten the adhesion of this device. 4. Spread powder open the small bag of powder adhesive and pour half (1/2) of it onto your gloved fingers. Spread the powder liberally on the skin around the anus; this dries the area where the latex bag will eventually be placed. (this would be approximately 2¿ circling around the anus. ) dust off any excess powder. Your gloved fingers should slide easily over the area if enough powder has been applied. 5. Apply liquid adhesive with swab, apply a light coating (about 1/3) of the adhesive solution around the anus, being certain to completely encircle the anus. 6. Apply remaining powder adhesive now apply the remainder of the adhesive powder over the first layer of liquid adhesive. 7. Apply remaining liquid adhesive apply the remaining 1/3 of the liquid adhesive over the second layer of powder adhesive, forming a skin barrier. 8. Essential: wait 2 minutes you must now wait 2 full minutes, allowing the solvent to evaporate, ensuring good adhesion. These 2 minutes are essential for a good seal. 9. Apply device. Press firmly. Grip the handle of bag-covered applicator and firmly press it onto the external anal area so that the anus is centered with the hole in the bag. Press firmly. Release the buttocks and firmly rock the applicator back and forth, and from side to side several times to insure complete contact with all the skin around the anus. Hold in place for 15 seconds to allow the adhesive time to set. 10. Remove applicator reach into the bag and gently remove the applicator from the bag. 11. Check patency place your gloved fingers into the bag, up to the anus, and check (1) that the bag has been properly centered with the anus and is not blocking the opening of the anus; and (2) the anus remains unobstructed. This can be verified by gently placing the tip of the gloved index finger just into the anus. 12. Apply closure clip fold the open end (tail) of the fcd¿ collection bag one time without wrinkling it. Clamp it in the closure clip, making sure that only the metal bars of the clip are compressing the bag. 13. Collection bag removal to remove the collection bag, wipe the adhesive remover along the adhesive seal while gently peeling the device from the skin 14. Connection to drainage bag liquid stool for bedside drainage bag: cut the end tip off the appendage at the bottom/side of the bag. Slide the plastic adapter over the tube-like appendage. Take the attachment end of the drainage system and tightly push it up into the end of the adapter. Emptying the latex collection bag: stool or flatus can be emptied from the collector by removing the clip from the bottom of the bag and draining the contents into a suitable receptacle. To avoid odor, after the bag has been drained, clean the opened end of the bag with soap and water to remove any remaining stool exposed to air. Replacing the bag: we recommend that the bag be replaced every 30 hours, at which time a reassessment of the patient¿s bowel status should be made. The bag should be emptied first and then removed by using the adhesive remover wipes included in the fcd¿ kit. 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. This is a single use device. Do not re-sterilize 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. After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and with applicable local, state and federal laws and regulations. " the device was not returned.
Event Description
It was reported that the fecal containment device tore when the patient was moved, and the device allegedly leaked.
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Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7570445
Report Number1018233-2018-02077
Device Sequence Number1
Product Code EXB
UDI-Device Identifier00801741050930
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2022
Device Catalogue Number190011
Device Lot NumberNGBX0546
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2018
Is This a Reprocessed and Reused Single-Use Device? No