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

Catalog Number	SCCS1001
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
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 patient was mobilized to a chair shortly before shift change as was typical for the sensica urine output unit, and when they went in for our shift change drip check, they could see that the height of the foley bag was just about level with my patient's bladder level when seated in the chair.There was a small amount of urine in the line, but none in the chamber.When they went in at 8 to get hourly measurements, they noticed that none of the urine was able to make it to the bag.So removed it to allow the urine to flow into the chamber and charted the removal and my reasoning.
Event or Problem Description
It was reported that the patient was mobilized to a chair shortly before shift change as was typical for the sensica urine output unit, and when they went in for our shift change drip check, they could see that the height of the foley bag was just about level with my patient's bladder level when seated in the chair.There was a small amount of urine in the line, but none in the chamber.When they went in at 8 to get hourly measurements, they noticed that none of the urine was able to make it to the bag.So removed it to allow the urine to flow into the chamber and charted the removal and my reasoning.Per follow up information received via task on 02sep2025, email response received noting that they believe the issue was caused by a design flaw in the sensica devices and the device would not be returning for evaluation.
Additional Manufacturer Narrative
The reported issue was inconclusive.Root cause was not able to be isolated as unit was not evaluated.The patient was mobilized to a chair shortly before shift change as was typical for the sensica urine output unit, and when they went in for our shift change drip check, they could see that the height of the foley bag was just about level with my patient's bladder level when seated in the chair.When they went in at 8 to get hourly measurements, they noticed that none of the urine was able to make it to the bag.Per follow up information, email response received noting that they believe the issue was caused by a design flaw in the sensica devices and the device would not be returning for evaluation.So removed it to allow the urine to flow into the chamber and charted the removal and my reasoning.A review of the risk document, (b)(4) rev 9, was reviewed for this investigation.The risk documentation was addressed in step #10.04.This occurrence does not introduce a new hazard or harm.It represents a known failure mode that has been assessed in the product risk management file in accordance with applicable regulatory standards and internal procedures.The associated risks continue to be monitored as part of ongoing post-market activities in compliance with both regulatory requirements and local procedures.The instructions-for-use are 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 is not required as the serial number is unknown.Based on the results of the investigation, no additional actions can be taken.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.

• 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: 22794605
• Report Number: 1018233-2025-06741
• Device Sequence Number: 8643182
• Product Code: EXS
• UDI-Device Identifier: 00801741215612
• UDI-Public: (01)00801741215612
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/13/2026

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: SCCS1001
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 01/14/2026
• 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