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

Model Number SCCS1002

Device Problem Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

Upon further review, bd has determined this event is not reportable.The device was not returned.

Event 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
• Type of Device: 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: 13693227
• MDR Text Key: 286924979
• Report Number: 1018233-2022-01117
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741215773
• UDI-Public: 00801741215773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCCS1002
• Device Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other