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

Model Number SMS002

Device Problems Break (1069); Leak/Splash (1354); Material Separation (1562)

Patient Problem 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 irrigation port on the dignishield broke off while the staff was trying to flush it, which caused water to squirt out.Per additional information received from the complainant via email on 13jan2020, it was noted that it was the clear piece inside the irrigation port that broke off.The complainant was reportedly unable to replace/reconnect it.

• 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
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9615724
• MDR Text Key: 181639339
• Report Number: 1018233-2020-00466
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• 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
• Date Manufacturer Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male