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

Model Number	SCCS1002
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
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.The information provided by bd represents all of 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 tube was not being detected on the sensica device when it was removed and replaced.It was also reported that the temperature reading was high for the patient but when reviewed in person the nurse stated the device was now reading normal.It was also observed that the temperature would fluctuate for 45 seconds before stabilizing when the nurse first connected the temperature sensing foley catheter to the device.Per follow up information received on (b)(6) 2022, there was no impact to the patient.Nurse got the tubing detected by being forceful and pushing the tubing fully inside the tube holder.Further test still had the tube being detected, so the device remained in use.The temperature reading appeared normal and stabilized.The patient case was continued.
Additional Manufacturer Narrative
The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause is temperature monitor module pcba failure.However this cannot be confirmed.The outcome of the repair cannot be determined at this time.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.It is unknown if the device did meet specifications and whether the device was influenced by the reported failure.The device was in use on a patient.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "ifu for properly charging the device: when first using the sensica uo system, the internal back-up battery may require charging.Plug the system into a medical grade wall supply using the power cord provided, and allow a 20 hours to charge battery.To avoid battery drainage over time, is recommended to keep the system plugged into the wall during use whenever possible.The battery will recharge when the system is plugged into a wall supply.Cautions: during system start up and in general practice, plug the sensica uo system into a wall power supply whenever possible.After using the system on batter back-up, plug it back into the wall power supply recharging and to avoid system shut down due to a drained battery." 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 tube was not being detected on the sensica device when it was removed and replaced.It was also reported that the temperature reading was high for the patient but when reviewed in person the nurse stated the device was now reading normal.It was also observed that the temperature would fluctuate for 45 seconds before stabilizing when the nurse first connected the temperature sensing foley catheter to the device.Per follow up information received on 12feb2022, there was no impact to the patient.Nurse got the tubing detected by being forceful and pushing the tubing fully inside the tube holder.Further test still had the tube being detected, so the device remained in use.The temperature reading appeared normal and stabilized.The patient case was continued.

• Brand Name: SENSICA UO SYSTEM
• Common Device Name: SENSICA UO SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13691231
• Report Number: 1018233-2022-01096
• Device Sequence Number: 12039971
• Product Code: EXS
• UDI-Device Identifier: 00801741215650
• UDI-Public: 00801741215650
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/10/2022

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 Model Number: SCCS1002
• Device Catalogue Number: SBTS1001
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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