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); Detachment of Device or Device Component (2907)

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 inflation port on the dignishield fell off.They were not able to deflate the cuff.

Event Description

It was reported that the inflation port on the dignishield fell off.They were not able to deflate the cuff.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿insufficient adhesive¿ with a potential root cause of "tip of syringe obstructed due to cured adhesive or parameters of dispenser out of specification".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: "to remove the catheter from the rectum, the retention cuff must be deflated.Attach the syringe to the green inflation port, and slowly withdraw all water from the retention cuff.11.System care, maintenance, and monitoring of device a.Take note of the black position indicator line that is printed in the proximal segment of the tsz.Observe its relative position to the patient¿s anus.Observe changes in the location of the position indicator band as a means to determine movement of the retention cuff in the patient¿s rectum.This may indicate the need for the cuff or drainage tube to be repositioned.B.Change the collection bag as needed.C.Secure the bag cap onto each used collection bag and discard according to institutional protocol for disposal of medical waste.D.To ensure unobstructed flow of fecal matter from the drainage tube to the collection bag, frequently verify that the catheter and collection bag are positioned so that the catheter is not twisted, kinked, or externally compressed.E.Frequently verify that waste is not accumulating in the catheter drainage tube.F.Verify patient is not lying on drainage tube or ports in such a manner as to potentially cause discomfort or localized prolonged pressure.G.Check the retention cuff volume regularly to ensure proper inflation." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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: 9512334
• MDR Text Key: 177621067
• Report Number: 1018233-2019-08200
• 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: 01/07/2020

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: 12/07/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/05/2020
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1