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

Catalog Number	SMS002
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that over the weekend, icu staff had experienced an issue with the rectal tube shown in the photo.The balloon of the rectal tube had been unable to deflate after inflation, and troubleshooting attempts had been unsuccessful.As a result, the nurse had proceeded to cut the rectal tube at the inflation port/line in order to deflate it and remove it from the patient.
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 over the weekend, icu staff had experienced an issue with the rectal tube shown in the photo.The balloon of the rectal tube had been unable to deflate after inflation, and troubleshooting attempts had been unsuccessful.As a result, the nurse had proceeded to cut the rectal tube at the inflation port or line in order to deflate it and remove it from the patient.
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.The labeling is found to be adequate, and it states: removal of device: a.To remove the catheter from the rectum, the retention cuff must be deflated.1) attach the 50 ml syringe to the green inflation port and slowly withdraw all water from the retention cuff.B.Make sure the inflation port remains parallel to the catheter in order to prevent kinking in the tubing and blockage of fluid.Refer to ideal patient positioning described in step 3a.1) once you have ensured the cuff is fully deflated, disconnect the syringe and discard.2) to facilitate removal, you may add an appropriate amount of lubricant to the anal sphincter prior to pulling back on the catheter to remove the cuff.3) grasp the catheter as close to the patient as possible and slowly slide the cuff out of the anus.Dispose of the device in accordance with institutional protocol for disposal of medical waste.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: d: 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: 24464319
• Report Number: 1018233-2026-01319
• Device Sequence Number: 10007381
• Product Code: KNT
• UDI-Device Identifier: 00801741045943
• UDI-Public: (01)00801741045943(11)251006(17)280831(10)NGKW0102
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/06/2026

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
• Device Lot Number: NGKW0102
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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: Unknown