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

Catalog Number	SCCS1002
Medical Device Problem Codes	Use of Device Problem (1670); Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer stated that the sensica urine output system was restarting during use.There was a damaged load cell.
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.
Additional Manufacturer Narrative
This event was a confirmed use of device, not attributed device malfunction.Submitting the investigation details as additional information.The reported issue was confirmed.The root cause identified is user-damage.A review of the risk document, (b)(4), was performed for this investigation.The reported event is addressed in step #20.08.Based on this review the risk is within the expected range.The labeling/ifu revision accompanying this serial number is not recorded in the dhr.The latest labeling revision will be reviewed for this investigation.The instructions-for-use under baw0335274 rev 2 is 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.Product labeling was reviewed for this investigation.The labeling is found to be adequate as the instructions for use state: "5.3.1 attach ring to attach the bd sensica¿ ring to the stand, orient the ring with the hanger upwards and use a clockwise motion to twist and lock the ring onto the ring interface.Note: in order to avoid damaging components, do not apply excessive force or torque the ring onto the system¿s ring interface when connecting the device.Do not turn the ring counterclockwise when attaching it.Note: do not push down on load cell console or tug/hang on ring as this can damage equipment." a review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Correction: d, e, f, g, 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 customer stated that the sensica urine output system was restarting during use.There was a damaged load cell.Per follow up information received via task on 15apr2025, they confirmed they found a different unit for the patient use.Device had already been sent in for repair.

• 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: 21516799
• Report Number: 1018233-2025-01431
• Device Sequence Number: 18256597
• Product Code: EXS
• UDI-Device Identifier: 00801741215773
• UDI-Public: (01)00801741215773(11)211101
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/07/2025

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
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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