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

Catalog Number	SMS002
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
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.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.
Event or Problem Description
It was reported that one probe partially broke the cuff joints during testing, without being installed.Afterwards, i received two more copies, which also broke during manual verification.It was reported that during the collection carried out by the carrier, we identified that, in addition to the dignishield unit corresponding to the lot (ngjyy312) reported in the complaint (b)(4), a second unit was also collected belonging to lot ngjs3478 for which we have no record of a complaint.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received 1 dignishield stool management system in opened container.Verified material number sms002 and batch number ngjs3478.Visual inspection noted that the piston valve connector was disconnected from the collection bag.Piston valve should be disconnected in packaging per dwg761095.Visual inspection noted that the adhesion on the ports appeared to be messy; however, no disconnects were present.It appeared that plastic material broke off into a-side of the dome valve.Risk, labelling, and dhr review are not required as the reported event was unconfirmed.Corrections made to tab(s) d, f, 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.
Event or Problem Description
It was reported that one probe partially broke the cuff joints during testing, without being installed.Afterwards, i received two more copies, which also broke during manual verification.It was reported that during the collection carried out by the carrier, we identified that, in addition to the dignishield unit corresponding to the lot (ngjyy312) reported in the complaint, a second unit was also collected belonging to lot ngjs3478.Per follow up information received via rcc on 25mar2026, stated that for lot#ngjs3478, during a test of the material, before to be installed, it had broken.Customer means the paths connected to the tube are disconnecting.The dome valve - looks like plastic material broke off into a-side of valve.Per notification from investigator on 16apr2026, it was reported that the dome valve - looks like plastic material broke off into a-side of valve was found during sample evaluation on 16apr2026.

• 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: 24590438
• Report Number: 1018233-2026-01664
• Device Sequence Number: 9440542
• Product Code: KNT
• UDI-Device Identifier: 00801741045943
• UDI-Public: (01)00801741045943(11)240703(17)270430(10)NGJS3478
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K133251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/09/2026

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: NGJS3478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 05/06/2026; 05/19/2026; 06/09/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/14/2026; 05/29/2026; 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• 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