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

Catalog Number	ENSMS002
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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.
Event or Problem Description
It was reported that the bard rectal tube malfunction: two of them the irrigation port broke and stool leaked everywhere.The last one actually had a small tear where the tubing comes out of the rectum, along the seam resulting in leakage.
Event or Problem Description
It was reported that the bard rectal tube malfunction: two of them the irrigation port broke and stool leaked everywhere.The last one actually had a small tear where the tubing comes out of the rectum, along the seam resulting in leakage.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.Instructions for use were reviewed for this investigation.The reported event is addressed within the labeling as it state.-position the length of the flexible drainage tube along the patient¿s leg, avoiding kinks, obstruction and tension.-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.6.Flushing of the drainage tube if the drainage tube becomes obstructed with fecal matter, flush the tube by filling a syringe with tap water, attaching the syringe to the purple ¿flush¿ port, and depressing the plunger.Make sure the flush port remains parallel to the catheter in order to prevent kinking in the tubing and blockage of the injected water.This is used to maintain an unobstructed flow of stool into the collection bag (figure 8).If repeated flushing with water does not return the flow of stool through the catheter, the device should be inspected to determine if there is an external obstruction (i.E.Pressure from a body part or piece of equipment).If no source of obstruction of the device is detected, use of the device should be discontinued.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections: d, h.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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 WITH ENFIT¿
• Common Device Name: 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: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23522780
• Report Number: 1018233-2025-10152
• Device Sequence Number: 9733145
• Product Code: KNT
• UDI-Device Identifier: 00801741113147
• UDI-Public: (01)00801741113147(11)250613(17)280430(10)NGKS1184
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: ENSMS002
• Device Lot Number: NGKS1184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male