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

Catalog Number	SCCS1002
Medical Device Problem Codes	Volume Accuracy Problem (1675); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
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 biomed stated that the sensica urine output device was sent down to biomed with issues starting a session.It was determined that the device had a damaged load cell with pins potentially bent.The customer reported that the device was logging urine output incorrectly and taking a long time to connect to start once the urine bag was connected.They have asked for more technical clarification regarding this information.
Event or Problem Description
It was reported that the biomed stated that the sensica urine output device was sent down to biomed with issues starting a session.It was determined that the device had a damaged load cell with pins potentially bent.The customer reported that the device was logging urine output incorrectly and taking a long time to connect to start once the urine bag was connected.They have asked for more technical clarification regarding this information.
Additional Manufacturer Narrative
This event was confirmed use related, not attributed to a device malfunction.Submitting the investigation details as additional information.The reported issue was confirmed.The root cause of the reported issue is rough handling of the device.The device was evaluated upon receipt.Device was received in with damaged load cell pins.Use-related.Load cell was replaced.Foam needs to be applied to optical sensor.Needs new revision of load cell ground cable.Applied foam to optical sensor and updated device's ground cable to current revision.Device passed all testing after repair.The complaint or reported issue was confirmed through other elements of the investigation to not be manufacturing related.The instructions-for-use under baw0335274 rev 2 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.Corrections: d, e, 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 URINE OUTPUT 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: 19961876
• Report Number: 1018233-2024-04817
• Device Sequence Number: 7064876
• Product Code: EXS
• UDI-Device Identifier: 00801741215773
• UDI-Public: (01)00801741215773(11)210621
• 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): 10/31/2024

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: 07/22/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• 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