MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)

Medical Device Problem Codes	Disconnection (1171); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
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.This report references a us equivalent device.The us udi equivalent for this product number is used.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 they were transferred a patient from the intensive care unit bed to the 3t bed when they noticed that a piece of the dignicare rectal tube had come off during the transfer.The part that came off was the green port, which was where they inflate or deflate the bulb to the tube with water.Before transferred to the floor they were able to successfully remove the old one they had to cut the rectal tube and that deflated the bulb and placed a new one.After arriving to 3t and explaining what happened, they were showing the 3t nurses where the old one had broken off.They lightly touched that for them to saw and some of the plastic holding the green port on, fell off.It almost appeared the only thing holding that on was a small amount of glue.

• Brand Name: UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)
• 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: 24622360
• Report Number: 1018233-2026-01825
• Device Sequence Number: 13220100
• Product Code: KNT
• UDI-Device Identifier: 00801741045943
• UDI-Public: (01)00801741045943
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 05/20/2026

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
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 05/29/2026
• 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