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

Model Number SCCS1002

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the sensica device had been sitting powered on to the side for days with the phantom touch present.The phantom touch prevented other buttons from the likely cleaning related.Per additional information received via follow-up on (b)(6) 2022, it was unknown if the sensica device was being used on a patient at the time of the reported event.It was stated that the date of event was (b)(6) 2022.The sensica device was evaluated in person by bd onsite, sensica device was rebooted, and the issue was resolved.

Manufacturer Narrative

The device was not returned.The reported issue was confirmed design related.The root cause of the reported issue is being investigated.The device did not meet specifications, and was influenced by the reported failure.It was unknown if the device was in use on a patient.The device history record review was not required as the complaint was addressed by existing capa.Labeling review was not required as the complaint was addressed by existing capa.H11:section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.

Event Description

It was reported that the sensica device had been sitting powered on to the side for days with the phantom touch present.The phantom touch prevented other buttons from the likely cleaning related.Per additional information received via follow-up on 23jan2022, it was unknown if the sensica device was being used on a patient at the time of the reported event.It was stated that the date of event was 11jan2022.The sensica device was evaluated in person by bd onsite, sensica device was rebooted, and the issue was resolved.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13471249
• MDR Text Key: 288779059
• Report Number: 1018233-2022-00442
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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