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

Model Number SMS002

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems Patient Problem/Medical Problem (2688); 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.The device was not returned.

Event Description

It was reported that the cuff of the dignishield was difficult to deflate.The device was removed by adding lubrication to the anus and pulling firmly.No medical intervention/patient injury reported.

Manufacturer Narrative

This report is being submitted past the regulatory timeframe.Please see attached letter for additional information.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: ¿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.".

Event Description

It was reported that the cuff of the dignishield was difficult to deflate.The device was removed by adding lubrication to the anus and pulling firmly.No medical intervention/patient injury reported.

• Brand Name: BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
• Type of Device: DIGNISHIELD
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8483634
• MDR Text Key: 141098900
• Report Number: 1018233-2019-01744
• 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: 05/29/2019

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 Model Number: SMS002
• Device Catalogue Number: SMS002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1