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

Model Number SCCS1002

Device Problem Device Sensing Problem (2917)

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

Event Date 10/04/2022

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 engineering unit have noted that the sensica device was not detecting the tube at start-up or on utility app.They believe the two tube issue devices needed the optical sensor repair (serial# (b)(4)) and (serial# (b)(4)).

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found that there was no allegation against product.H11:section a through f - 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 Description

It was reported that the engineering unit have noted that the sensica device was not detecting the tube at start-up or on utility app.They believe the two tube issue devices needed the optical sensor repair (serial# (b)(6).

• 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: 15606992
• MDR Text Key: 306621706
• Report Number: 1018233-2022-07847
• 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: 04/03/2023

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: SCCS1002
• Device Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: No
• 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