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

Catalog Number	SCCS1002E
Medical Device Problem Codes	Nonstandard Device (1420); Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 per wo evaluation, the sensica urine output device body control module (bcm) was unable to pass the screen calibration portion of software upgrade.Needs new body control module (bcm).
Event or Problem Description
It was reported that the per wo evaluation, the sensica urine output device body control module (bcm) was unable to pass the screen calibration portion of software upgrade.Needs new body control module (bcm).
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is a failed body control module.The device was evaluated upon receipt.Devices bcm is unable to pass the screen calibration portion of software upgrade.Needs new bcm.Device bcm was replaced.Upgraded to current software revision.Testing was performed.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions are needed.Correction: d, f, h.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.

• Brand Name: SENSICA UO SYSTEM
• Common Device Name: SENSICA DEVICE
• 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: 23008810
• Report Number: 1018233-2025-07722
• Device Sequence Number: 21258212
• Product Code: EXS
• UDI-Device Identifier: 00801741219016
• UDI-Public: (01)00801741219016(11)210330
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/09/2026

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: SCCS1002E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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