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

Model Number	SMS2B1L
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer had ordered 10 each per case of dignicare stool management system collection bags, but they only received the bag and not the other components.Customer stated that based on the manufacturer part number sms2b1l, it appeared the item should come with the following: a catheter tube assembly, a 60cc syringe, a collection bag, a syringe of lubricating jelly, a biological odor eliminator and a tube clamp.The device has no components made of natural rubber latex.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the customer had ordered 10 each per case of dignicare stool management system collection bags, but they only received the bag and not the other components.Customer stated that based on the manufacturer part number sms2b1l, it appeared the item should come with the following: a catheter tube assembly, a 60cc syringe, a collection bag, a syringe of lubricating jelly, a biological odor eliminator and a tube clamp.The device has no components made of natural rubber latex.
Additional Manufacturer Narrative
The reported event was unconfirmed because that there were no other components sent instead of dignishield collection bags in this product.No root cause could be found because the reported event was unconfirmed.The device did not fail to meet relevant specifications.Based on patient code 2645 the product does not appear to have been used.The product had not caused the reported failure.The device was not returned for evaluation.A dhr review was not required because the reported event is unconfirmed.Based on the results of the investigation, no additional actions are needed.As the reported event is unconfirmed a labeling review is not required.Correction: g 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.The device was not returned.

• Brand Name: BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM COLLECTION BAGS
• Common Device Name: DIGNISHIELD STOOL MANAGEMENT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13839694
• Report Number: 1018233-2022-01465
• Device Sequence Number: 1401670
• Product Code: KNT
• UDI-Device Identifier: 00801741045967
• UDI-Public: (01)00801741045967
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: Lay User/Patient
• Device Model Number: SMS2B1L
• Device Catalogue Number: SMS2B1L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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