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

Catalog Number	SCCS1002
Medical Device Problem Code	Computer Operating System Problem (2898)
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.
Additional Manufacturer Narrative
This mdr is being retracted as it is a cascading event of a record already submitted 1018233-2024-04830.
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 record is being submitted as a correction to the date received by manufacturer previously submitted.Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.Udi format updated with available product information per gudid.Correction: g.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: 19980980
• Report Number: 1018233-2024-04893
• Device Sequence Number: 8375000
• Product Code: EXS
• UDI-Device Identifier: 00801741215773
• UDI-Public: (01)00801741215773
• 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,Followup
• Report Date (Section B): 11/14/2024

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?: No
• 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: Not provided; 11/11/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/30/2024; 11/14/2024
• 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