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

Catalog Number	SCCS1002E
Medical Device Problem Codes	No Display/Image (1183); Computer Operating System Problem (2898)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
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 bd clinical manager called and stated that the sensica devices hour display was frozen on the previous 3 hours and did not update to reflect the current hour.The ml was still reading correctly and accurately but the hour display was frozen.
Additional Manufacturer Narrative
The reported issue was unconfirmed.At this time, the root cause of the reported event could not be determined.The reported issue could not be reproduced as the time was displayed correctly throughout the entirety of the testing.The sensica urine output system was evaluated upon receipt.(sensica) no error code observed.Devices pcb was reflashed, time was displayed correctly throughout the entirety of testing.Testing was performed in accordance with (b)(4).Device passed all applicable testing.Dhr, risk, and labeling reviews are not required as the reported event is unconfirmed.No additional actions can be taken at this time.Corrections: d, f, h.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 bd clinical manager called and stated that the sensica devices hour display was frozen on the previous 3 hours and did not update to reflect the current hour.The ml was still reading correctly and accurately but the hour display was frozen.Per additional information received via mail on 02jul2025, the unit will be sent in for evaluation.Customer service has provided a return shipping label.Wanted to confirm the best location for its return.The issue was resolved by powering off the device, waiting 10 seconds, and restarting it.Upon restart, the time and hour were correct, and urine output monitoring resumed.However, previous data did not display, despite using the same ring and patient id.The patient completed therapy on the device.There was no impact to the patient.The only effect was on nursing workflow, as hourly output from 5 am to 10 am was unavailable.The rn had to manually empty the collection system and average the output for those hours.

• Brand Name: SENSICA UO SYSTEM
• Common Device Name: SENSICA
• 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: 22320819
• Report Number: 1018233-2025-04949
• Device Sequence Number: 18389478
• Product Code: EXS
• UDI-Device Identifier: 00801741219016
• UDI-Public: (01)00801741219016(11)210301
• 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): 01/15/2026

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: SCCS1002E
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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