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

Catalog Number SMS002

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250)

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

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 the retention balloon on the dignishield prematurely deflated loosing all of the water.Water was added once more but the balloon would not stay inflated.The patient did not require medical intervention, no other concerns or difficulties were experienced.The patient had a new dignishield placed without difficulty.

Manufacturer Narrative

The device was not returned for evaluation.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: "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 lead to device failure and/or lead to injury, illness or death of the patient.".

Event Description

It was reported that the retention balloon on the dignishield prematurely deflated loosing all of the water.Water was added once more but the balloon would not stay inflated.The patient did not require medical intervention, no other concerns or difficulties were experienced.The patient had a new dignishield placed without difficulty.

• Brand Name: BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
• Type of Device: DIGNISHIELD STOOL MANAGEMENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8249444
• MDR Text Key: 133207406
• Report Number: 1018233-2019-00260
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: SMS002
• Device Lot Number: NGCU2541
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1