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

Model Number SCCS1002E

Device Problem Volume Accuracy Problem (1675)

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

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the user set up the sensica system, did not add fluid and did not disturb the system.In the first hour, the system read 7ml and the second hour it read 3ml.This was outside of the accuracy specification that mss would expect when the system was not being disturbed.Per follow up information received via email on (b)(6)2023, they have decided to keep the sensica and would continue to monitor this unit for issues.If these issues continue, they would send it for evaluation and repair.

Event Description

It was reported that the user set up the sensica system, did not add fluid and did not disturb the system.In the first hour, the system read 7ml and the second hour it read 3ml.This was outside of the accuracy specification that mss would expect when the system was not being disturbed.As per follow up information received via email on 31jan2023, they have decided to keep the sensica and would continue to monitor this unit for issues.If these issues continue, they would send it for evaluation and repair.

Manufacturer Narrative

The reported issue was confirmed.The identified root causes is ¿software issues¿ as it was confirmed that due to certain software steps being interrupted, that uo was not being reported or calculated correctly.The device did not meet specifications, and was influenced by the reported failure.The device was not in use on a patient.The device history record review is not required.Labeling review is not required because labeling could not have prevented this issue.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.H3 other text : the device was not returned.

• Brand Name: SENSICA UO SYSTEM
• Type of Device: SENSICA DEVICE
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16334889
• MDR Text Key: 309149745
• Report Number: 1018233-2023-00742
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741219016
• UDI-Public: 00801741219016
• 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: 06/01/2023

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
• Device Operator: Health Professional
• Device Model Number: SCCS1002E
• Device Catalogue Number: SCCS1002E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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