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The reported event was confirmed however the cause was unknown.One sample was confirmed to exhibit the reported failure.Visual evaluation of the returned sample noted 11 unopened (within original package) dignishield boxes with 2 unused dignishield bags in each box were received.5 samples were tested.Visual inspection of the sample noted no obvious visible defects such as holes or damage.The 5 samples were filled with methylene blue solution (3 drops 1 percent aqueous methylene blue per 100 ml distilled water) and none of the sample were leaked.Visual evaluation of the photo sample noted one opened (without original package) dignishield.The evaluation of the photo noted that there was a leakage of fecal matter around a dignishield tubing shaft tear.A potential root cause for this failure mode could be due to anomalies on the tube.The device did not meet the specifications and was influenced by the reported failure.The product used for the treatment.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "indications for use: the bard dignishield stool management system (sms) with odor barrier properties is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients and to provide access for the administration of medications.Adult use only.The bard dignishield sms catheter tube assembly consists of a catheter body and collection bag assembly that is primarily constructed of a proprietary copolymer material called permalene, bonded to a low-pressure retention cuff and transsphincteric zone (tsz) primarily constructed of silicone material.The permalene catheter and collection bag material is designed to minimize permeation of gas and water vapor.The low-pressure retention cuff is designed to retain the device in the rectum.The tube opening at the cuff is funnel shaped to aid in diverting the stool into the drainage tube.The cuff leads to the tsz segment, which is designed to minimize dilation of the sphincter during use while providing a channel for fecal matter to pass through drainage tube and into the collection bag.Along the drainage tube are three lumens, each with a separate access port.The green inflation port is used to inflate/deflate the cuff.The clear irrigation port is used to infuse water at the end of the retention cuff and to provide access for the administration of medication.The purple flush port (flush) is used to infuse water through slits for the entire length of the drainage tube to assist drainage of fecal matter.A sample port on the drainage tube allows for the collection of stool samples through a slip-tip syringe.A piston valve connector located on the end of the drainage tube of the catheter attaches to the collection bag hub socket.When the collection bag is disengaged from the catheter, the catheter and bag automatically close to prevent spillage.A bag cap is provided to secure the contents of the collection bag when the catheter is removed.The 50 ml syringe and lubricating jelly syringe are used in the preparation and use of the catheter.The mediaire biological odor eliminator may be used as an air freshener in the room.Do not spray on patient or device.The tube clamp is used to retain medication during administration of medication.Contraindications: ¿ do not use for more than 29 consecutive days.The uninterrupted use for this device, including immediate replacement with the same or an identical device, is intended to be 29 days or less.¿ do not use on patients known to be sensitive to or allergic to any components within the system.¿ do not use on patients who had lower large bowel or rectal surgery within the last year.¿ do not use on patients with any rectal or anal injury, severe rectal or anal stricture or stenosis (or on any patient if the distal rectum cannot accommodate the inflated cuff), confirmed rectal or anal tumor, severe hemorrhoids, or fecal impaction.¿ do not use on patients with suspected or confirmed rectal mucosa impairment, i.E.Severe proctitis, ischemic proctitis, mucosal ulcerations.¿ do not use on patients with indwelling rectal or anal device (e.G.Thermometer) or delivery mechanism (e.G.Suppositories) or enemas in place.Warnings: ¿ 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.¿ do not use if package is opened or damaged.¿ do not use improper amount or type of fluids for irrigation/flush or cuff inflations.Never use hot liquids.¿ do not over inflate retention cuff.¿ use only gravity or slow manual irrigation.Do not connect mechanical pumping devices to catheter irrigation port.Do not irrigate patient with compromised intestinal wall integrity.¿ rectal bleeding should be investigated to ensure no evidence of pressure necrosis from the device.Discontinuation of use is recommended if pressure necrosis is evident.¿ abdominal distention that occurs while using the device should be investigated.¿ prolonged traction on the catheter may result in the retention cuff migrating into the anal canal which may result in mucosal lesion, temporary or permanent clinical sphincter dysfunction, or catheter expulsion.¿ solid or soft-formed stool cannot pass through the catheter and will obstruct the opening.The use of the device is not indicated for patients with solid or soft formed stool.¿ single use only.Do not reuse.Reuse and/or packaging may create a risk possibly resulting in patient or user infection.Structural integrity and/or essential material and design characteristics of the device, may be compromised, which may lead to device failure and or lead to injury, illness or death of the patient.Precautions: ¿ caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.¿ do not sterilize.¿ close attention should be paid to the use of the device in patients who have inflammatory bowel conditions.The physician should determine the degree and location of inflammation within the colon/rectum prior to considering use of this device in patients with such conditions.Ensure retention cuff and funnel are folded into a low profile form prior to insertion.¿ patients with very weak sphincter muscles may not be able to retain the device in place and may experience increased leakage of stool.¿ if the catheter becomes blocked with solid particles, it may be flushed with water.If obstruction of the catheter is due to solid stool, use of the device should be discontinued.¿ to avoid injury to the patient, do not insert anything into the anal canal while this device is in place (e.G.Thermometer, suppositories, etc.).Remove the device prior to insertion of anything into the anal canal.¿ notify a physician if any of the following occur: 1) persistent rectal pain 2) rectal bleeding 3) abdominal distension ¿ if the patient¿s bowel control, consistency and frequency of stool begin to return to normal, discontinue use of the device.¿ caution should be exercised in using this device in patients who have a tendency to bleed from either anticoagulant or antiplatelet therapy or underlying disease.¿ when using the tube clamp for medication delivery, ensure the patient is closely monitored and is not allowed to lie on the tube clamp.¿ ensure the tube clamp is only used during medication delivery and for the prescribed dwell time.Do not leave the tube clamp on the drainage tube for longer than the prescribed dwell time." h11: section a through f - the information provided by bd 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 bd.H3 other text : the actual/suspected device was inspected.
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