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.The reported event is addressed within the labeling as it states".Along the drainage tube are three lumens, each with a separate access port.The green inflation port (¿inf(45ml)/inflate to 45ml¿) is used to inflate/deflate the cuff.The clear irrigation port (¿irrig¿) is used to infuse water at the end of the retention cuff and to provide access for the administration of medication.The purple flush port (¿flush¿) is used to infuse water through slits for the entire length of the drainage tube to assist drainage of fecal matter.(figure 2) a sample port on the drainage tube allows for the collection of stool samples through a slip-tip syringe.Warnings: do not use improper amount or type of fluids for irrigation/flush or cuff inflations.Never use hot liquids.Use only gravity or slow manual irrigation.Do not connect mechanical pumping devices to catheter irrigation port.Do not irrigate patient with compromised intestinal wall integrity.If the funnel or retention cuff area becomes clogged with solid particles, it may be irrigated by filling the syringe with water, attaching the syringe to the clear irrigation port and depressing the plunger.Attach an enfit -compatible syringe with the medication to be delivered (dosage as indicated and as prescribed by the treating physician) to the clear irrigation port (labeled ¿irrig¿).Elevate the drainage tubing to facilitate medication retention and infuse the prescribed amount of medication.To ensure delivery of medication into the rectum, immediately flush the irrigation line with at least 10 ml of water (or volume per physician's orders).A dhr could not be performed since no lot number was provided.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 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: 23522767
• Report Number: 1018233-2025-10155
• Device Sequence Number: 21265644
• Product Code: KNT
• UDI-Device Identifier: 00801741113147
• UDI-Public: (01)00801741113147(11)250513(17)280229(10)NGKQ3538
• 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): 01/09/2026

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: ENSMS002
• Device Lot Number: NGKQ3538
• 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: 01/09/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2025
• 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