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

Catalog Number SMS002

Device Problems Disconnection (1171); Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2023

Event Type  malfunction  

Event Description

It was reported that the patient was hospitalized due to pulmonary septic shock and use of vasoactive drugs at high flow rate.It was stated that he evolved with continuous and persistent diarrhea and stage 4 sacral pressure injury.The use of the dignishield rectal probe started on 07/27, with irrigation in the white pathway 1 time at each shift.On 08/18, a large amount of feces leaked into the bed.When inspecting the device, a rupture was identified in the probe in the irrigation route, without the connector, and the content was leaking through the route.Occlusion of the pathway was performed with tape and continued use of the device.On 08/22, looseness was observed in the connection of the purple pathway (flush) with the probe.The patient is still with diarrhea and the tube was valid until 08/25.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.

Manufacturer Narrative

The reported event was confirmed cause unknown.1 sample were confirmed to exhibit the reported failure.The device had not met specifications.A potential root cause for this failure mode could be ¿missing adhesive due to incorrect and/or not clear manufacturing instructions".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: "instructions for use: warning/advertisement/advertencia: 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.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 medi-aire® 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.Directions for use: pump sprayer once or twice.Direct spray away from patient.Contains: water, sd alcohol 40, triethylene glycol, benzethonium chloride, d&c color, tetrasodium edta.Caution: may be harmful if swallowed.Avoid eye contact.Keep out of reach of children.General guidelines: the device may be replaced as needed, to perform patient assessment.For medical or technical questions, please contact medical services and support 800-227-3357.If further information or guidelines are needed, please contact bard medical, at the address below: c.R.Bard, inc.Covington, ga 30014 usa 1-800-526-4455 assembled in mexico www.Bardmedical.Com bard, dignishield, medi-aire and permalene are trademarks and/or registered trademarks of c.R.Bard, inc.©2020 c.R.Bard, inc.All rights reserved.11.System care, maintenance, and monitoring of device a.Take note of the black position indicator line that is printed in the proximal segment of the tsz.Observe its relative position to the patient¿s anus.Observe changes in the location of the position indicator band as a means to determine movement of the retention cuff in the patient¿s rectum.This may indicate the need for the cuff or drainage tube to be repositioned.B.Change the collection bag as needed.C.Secure the bag cap onto each used collection bag and discard according to institutional protocol for disposal of medical waste.D.To ensure unobstructed flow of fecal matter from the drainage tube to the collection bag, frequently verify that the catheter and collection bag are positioned so that the catheter is not twisted, kinked, or externally compressed.E.Frequently verify that waste is not accumulating in the catheter drainage tube.F.Verify patient is not lying on drainage tube or ports in such a manner as to potentially cause discomfort or localized prolonged pressure.G.Check the retention cuff volume regularly to ensure proper inflation." h11: section a through f - the information provided by bd represents all 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.

Event Description

It was reported that the patient was hospitalized due to pulmonary septic shock and use of vasoactive drugs at high flow rate.It was stated that he evolved with continuous and persistent diarrhea and stage 4 sacral pressure injury.The use of the dignishield rectal probe started on (b)(6), with irrigation in the white pathway 1 time at each shift.On (b)(6), a large amount of feces leaked into the bed.When inspecting the device, a rupture was identified in the probe in the irrigation route, without the connector, and the content was leaking through the route.Occlusion of the pathway was performed with tape and continued use of the device.On (b)(6), looseness was observed in the connection of the purple pathway (flush) with the probe.The patient is still with diarrhea and the tube was valid until (b)(6).Per additional information via email from ibc on 15sep2023, it was stated that there was no harm to the patient or caregiver due to the leak.There was continuous leakage of contents into the patient's bed and irrigation could no longer be performed.The flush continued to be made, even with the loose connection.The tube was removed on (b)(6)(it remained in place for 29 days) and the patient underwent a colostomy.The patient underwent a colostomy, but because they still had diarrhea and stage 4 pressure ulcers and the end of the rectal probe period.If what happened with the irrigation route had happened earlier, it would have rendered the probe useless, due to overflow.As happened close to the removal of the device, an occlusion was performed with adhesive tape.It was removed on (b)(6) and the patient underwent a colostomy.It was stated that the no photos of the laxity on the purple route and no sample available for analysis.

• Brand Name: BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
• Type of Device: STOOL MANAGEMENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17753134
• MDR Text Key: 324007682
• Report Number: 1018233-2023-06780
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K133251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMS002
• Device Lot Number: NGGU1817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female