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

Model Number SMS002

Device Problem Biocompatibility (2886)

Patient Problem Pressure Sores (2326)

Event Date 11/30/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the facility had a couple of medical device related pressure injuries that were being attributed by the placement of the dignishield fecal management system.Complainant enquired if there was any training that could be implemented or if any guidance could be provided on this.It was unknown what medical intervention was provided for the pressure injuries.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "materials of construction are not biocompatible".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.The dhr review could not be performed without a lot number.Based on the results of the investigation, no additional actions are needed.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 60 ml syringe, a syringe of lubricating jelly and a biological odor eliminator.The device has no components made of natural rubber latex.¿ catheter tube assembly (figure 1 includes collection bag) ¿ collection bag ¿ 60 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 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.(figure 2) 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 60 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." the device was not returned.

Event Description

It was reported that the facility had a couple of medical device related pressure injuries that were being attributed by the placement of the dignishield fecal management system.Complainant enquired if there was any training that could be implemented or if any guidance could be provided on this.It was unknown what medical intervention was provided for the pressure injuries.

• Brand Name: BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
• Type of Device: STOOL MANAGEMENT SYSTEM
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13006809
• MDR Text Key: 282976340
• Report Number: 1018233-2021-08079
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741045943
• UDI-Public: (01)00801741045943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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