MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 SENSICA URINE OUTPUT SYSTEM; SENSICA UO SYSTEM

Catalog Number	SCCS1002
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
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: 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 the have seen some error arise on the sensica urine output system a couple of times and was wondering if knew why or how to fix it.Randomly during a shift, it would stop showing the hourly outputs and combine 3 or more hours of output, so they would not see what they put out each hour.Per unit nurse manager, no harm occurred to patient.Bedside rn stopped therapy, restarted device, and resumed therapy would without issue.
Additional Manufacturer Narrative
The device was not returned.The reported issue was inconclusive.At this time, the root cause of the reported event could not be determined.Per unit nurse manager, no harm occurred to patient.Bedside rn stopped therapy, restarted device, and resumed therapy would without issue.Per additional information received, they were sure which one was doing it so they could not send it.They have not experienced the issue since then.The labeling/ifu revision accompanying this serial number is not recorded in the dhr.The latest labeling revision was reviewed for this investigation.The instructions-for-use were found to be adequate.The ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.A dhr review is not required as the serial number is unknown.Correction: b 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 the have seen some error arise on the sensica urine output system a couple of times and was wondering if knew why or how to fix it.Randomly during a shift, it would stop showing the hourly outputs and combine 3 or more hours of output, so they would not see what they put out each hour.Per unit nurse manager, no harm occurred to patient.Bedside rn stopped therapy, restarted device, and resumed therapy would without issue.Per follow up information received via task on (b)(6) 2025, they were sure which one was doing it so they could not send it.They have not experienced the issue since then.

• Brand Name: SENSICA URINE OUTPUT SYSTEM
• Common Device Name: SENSICA UO SYSTEM
• 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: 22194242
• Report Number: 1018233-2025-04466
• Device Sequence Number: 13196482
• Product Code: EXS
• UDI-Device Identifier: 00801741215773
• UDI-Public: (01)00801741215773
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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: SCCS1002
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown