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

Catalog Number SMS002

Device Problems Inability to Irrigate (1337); Obstruction of Flow (2423)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2019

Event Type  malfunction  

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 water could not be injected into the flush port on the 3rd day of use.The device was replaced.

Event Description

It was reported that water could not be injected into the flush port on the 3rd day of use.The device was replaced.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿unable to flush catheter¿ with a potential root cause of ¿arm occluded or detaches¿.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: ¿¿ catheter tube assembly (figure 1 includes collection bag) ¿ collection bag ¿ 60ml syringe ¿ lubricating jelly syringe (10ml) ¿ instructions for use ¿ 1 bottle (1oz) 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`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.".

• Brand Name: BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
• Type of Device: DIGNISHEALD
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9386213
• MDR Text Key: 177368819
• Report Number: 1018233-2019-07608
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K133251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMS002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1