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

Model Number SMS002

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 08/16/2021

Event Type  malfunction  

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 stated that there was a tear in dignisheild tubing and it was unknown whether it was caused due to error by staff or it was product issue.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "anomalies on the tube".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 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 stated that there was a tear in dignisheild tubing and it was unknown whether it was caused due to error by staff or it was product issue.Per follow-up information received via bmd field assurance mailbox on 13sep2021, no additional information is available and there is no sample for return.Also stated, the only other issue that was indicated was that the nurse had a hard time deflating the balloon to remove the tube.Per follow up information received on 18oct2021, the balloon had to be taken out inflated.

• Brand Name: BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
• Type of Device: DIGNISHIELD 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: 12439709
• MDR Text Key: 270320916
• Report Number: 1018233-2021-05500
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741045943
• UDI-Public: (01)00801741045943
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• 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: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 03/08/2022
• 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