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

Catalog Number	SCCS1002
Medical Device Problem Codes	Device Sensing Problem (2917); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
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 problem stated was the sensica urine output system did not read the tubing in the sensor on the side.The front 3 pins look good on this unit in the front where the o ring connects.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is that the optical sensor is not situated correctly in the housing causing it to read incorrectly.The device was evaluated upon receipt.Device experiencing optical sensor issues is attributed to the device not having the foam applied to the sensor.Tubing not detected code 18 seen.Applied foam to optical sensor.Updated load cell ground cable to new revision.Device passed all final functional verification requirements.Testing was performed.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.A dhr review is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.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.
Event or Problem Description
It was reported that the problem stated was the sensica urine output system did not read the tubing in the sensor on the side.The front 3 pins look good on this unit in the front where the o ring connects.

• Brand Name: SENSICA URINE OUTPUT SYSTEM
• Common Device Name: SENSICA URINE OUTPUT 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: 21886772
• Report Number: 1018233-2025-02917
• Device Sequence Number: 8162201
• Product Code: EXS
• UDI-Device Identifier: 00801741215773
• UDI-Public: (01)00801741215773(11)210728
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/20/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• 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