MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM COLLECTION BAGS; DIGNISHIELD COLLECTION BAG

Model Number	SMS2B1L
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2020
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.
Event or Problem Description
It was reported that the dignishield rectal tube bowel irrigation port for bowel medication allegedly leaked while attempting to inject diluted medication with a luer-lock syringe.Supposedly, the valve in the port came out and would be attached to the syringe.However, if replaced it would leak again.The rectal tube was replaced and kept to be submitted back to the company for assessment.
Event or Problem Description
It was reported that the dignishield rectal tube bowel irrigation port for bowel medication allegedly leaked while attempting to inject diluted medication with a luer-lock syringe.Supposedly, the valve in the port came out and would be attached to the syringe.However, if replaced it would leak again.The rectal tube was replaced and kept to be submitted back to the company for assessment.
Additional Manufacturer Narrative
Per review, bard/bd has determined that this mdr is a duplicate record and was previously reported.H11:section a through f - the information provided by bd represents all of 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 COLLECTION BAGS
• Common Device Name: DIGNISHIELD COLLECTION BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10228228
• Report Number: 1018233-2020-04306
• Device Sequence Number: 536535
• Product Code: KNT
• UDI-Device Identifier: 00801741045967
• UDI-Public: (01)00801741045967
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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 Model Number: SMS2B1L
• Device Catalogue Number: SMS2B1L
• Device Lot Number: NGEN4794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1