MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM

Model Number SMS002

Device Problem Biocompatibility (2886)

Patient Problems Pressure Sores (2326); Stomach Ulceration (4488)

Event Date 10/25/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that there were 2 patients who had developed rectal ulcers/bleeding.It was stated that a rectal tube was inserted for the patient on (b)(6) 2020 post cardiac surgery with iabp insitu.The patient was noted to have an ulcer on the inferior edge of anus after 6 days of placement.The rectal tube was removed and suspected that it was due to the rectal tube.Patient experienced frank melena with clots after repositioning it on (b)(6) 2020.Patient started bleeding again rectally on (b)(6) 2020 and the bleeding stopped next day.It was unknown what medical intervention was provided.Per additional information received from ibc via email on 09may2021, fecal matter was bypassing from the get go.The rectal rube was not working properly for the 13 days and bleeding from rectal ulcer was noted on the same day the tube was removed.Patient went for scope and possible stasis.Per additional information received from ibc via email on 10may2021, the date of device inserted for one patient was (b)(6) 2020 and the date of removal was (b)(6) 2020.The date of device inserted for second patient was (b)(6) 2020.

Manufacturer Narrative

The reported event was inconclusive.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.No sample was returned for evaluation.A potential root cause for this failure could be due to "materials of construction are not biocompatible".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.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.Device description: the bard® dignishield® sms device consists of a catheter tube assembly, a collection bag (figure 1), a 50 ml syringe, a syringe of lubricating jelly and a biological odor eliminator.The device has no components made of natural rubber latex.Contents: ¿ catheter tube assembly (figure 1 includes collection bag) ¿ collection bag ¿ 50 ml syringe ¿ lubricating jelly syringe (10 ml) ¿ instructions for use ¿ 1 bottle (1 oz) of medi-aire® biological odor eliminator ¿ tube clamp 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 trans-sphincteric 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 (¿inf(45ml)/inflate to 45ml¿) is used to inflate/deflate the cuff.The clear irrigation port (¿irrig¿) is used to infuse water at the end of the retention cuff and to provide access 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 instructions for use 1.Preparation of sms prior to insertion a.Verify the retention cuff has been completely deflated.This can be done by squeezing the cuff to ensure there is no residual air inside the device.1) if air remains within the cuff, attach the 50 ml syringe to the green inflation port and withdraw all remaining air from the cuff.B.After the cuff has been fully deflated, fill the syringe with 45 ml of water and set aside.C.Using a permanent marker, record the catheter insertion date on the label located on the piston valve connector.2.Collection bag connection a.Attaching the collection bag: 1) attach the collection bag to the piston valve connector on the catheter by pulling back on the green trigger switch and engaging the piston valve connector onto the collection bag hub socket.2) ensure that the green ring at the base of the collection bag hub socket is not visible.The green ring at the base of the collection bag hub socket will not be visible when the piston valve is properly connected.3.Preparation of patient a.The preferred patient position for catheter insertion is the left lateral knee-chest position, although the patient¿s clinical situation may dictate the use of an alternate position.The goal of patient positioning is to maximize sphincter relaxation to ease catheter insertion.B.Perform a digital rectal exam to evaluate for fecal impaction.If a fecal impaction is present, disimpaction procedure and device insertion may occur at the discretion of the healthcare professional.4.Insertion of device a.Unfold the length of the catheter to lay flat on the bed, extending the collection bag towards the foot of the bed.B.Attach the 50 ml syringe filled with 45 ml of water to the inflation port, but do not inflate.C.Insert the inflation cuff using a four-step process: 1) as previously stated in step 1, ¿preparation of sms prior to insertion¿, ensure the retention cuff is completely deflated.2) holding the left point of the cuff between the thumb and index finger, fold the top right point of the cuff down and to the left in a 45 degree angle , in order to create a conical shape with a leading edge for easy insertion.3) generously coat the patient¿s anus with lubricating jelly.4) gently insert the cuff end through the anal sphincter until the cuff is beyond the external orifice and well inside the rectal vault." h11: section a through f - 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.H3 other text : the device was not returned.

Event Description

It was reported that there were 2 patients who had developed rectal ulcers/bleeding.It was stated that a rectal tube was inserted for the patient on (b)(6) 2020 post cardiac surgery with iabp insitu.The patient was noted to have an ulcer on the inferior edge of anus after 6 days of placement.The rectal tube was removed and suspected that it was due to the rectal tube.Patient experienced frank melena with clots after repositioning it on (b)(6) 2020.Patient started bleeding again rectally on (b)(6) 2020 and the bleeding stopped next day.It was unknown what medical intervention was provided.Per additional information received from ibc via email on (b)(6) 2021, fecal matter was bypassing from the get go.The rectal rube was not working properly for the 13 days and bleeding from rectal ulcer was noted on the same day the tube was removed.Patient went for scope and possible stasis.Per additional information received from ibc via email on (b)(6) 2021, the date of device inserted for one patient was (b)(6) 2020 and the date of removal was (b)(6) 2020.The date of device inserted for second patient was (b)(6) 2020.

• Brand Name: BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
• Type of Device: DIGNISHIELD
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11871080
• MDR Text Key: 252217748
• Report Number: 1018233-2021-02990
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741045943
• UDI-Public: (01)00801741045943
• Combination Product (y/n): N
• PMA/PMN Number: K133251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SMS002
• Device Catalogue Number: SMS002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other