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

Catalog Number	SMS002
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
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.Sections 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 customer experienced issues with dignishield, specifically leakage caused by small holes approximately 6 inches from the insertion point.A new incident was reported today.The device had been placed on feb 18 at 09:28 in the cardiac unit.When the patient arrived in the icu, staff observed leakage, and the tubing appeared to have a slash near the same location (about 6 inches down).The lot number was not available.The device was replaced, and no further issues were reported.
Event or Problem Description
It was reported that the customer experienced issues with dignishield, specifically leakage caused by small holes approximately 6 inches from the insertion point.A new incident was reported today.The device had been placed on (b)(6) at 09:28 in the cardiac unit.When the patient arrived in the icu, staff observed leakage, and the tubing appeared to have a slash near the same location (about 6 inches down).The lot number was not available.The device was replaced, and no further issues were reported.
Additional Manufacturer Narrative
The reported event was confirmed - cause unknown.One photo was received for evaluation where the tears and small holes were visible on the tubing where the leakage was present.Product labeling was reviewed for this investigation and found adequate.Dhr is unable to be performed as the lot number is unknown.Udi format updated with available product information per gudid.H11: sections 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
• 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: 24464306
• Report Number: 1018233-2026-01306
• Device Sequence Number: 15786837
• Product Code: KNT
• UDI-Device Identifier: 00801741045943
• UDI-Public: (01)00801741045943
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: SMS002
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown