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

Catalog Number SCCS1001

Device Problems Use of Device Problem (1670); Volume Accuracy Problem (1675)

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

Event Date 02/11/2021

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 urine scale of sensica device was sent for repair.

Event Description

It was reported that the urine scale of sensica device was sent for repair.

Manufacturer Narrative

Per additional information received, it has been determined that this is not a reportable event.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 actual/suspected device was inspected.

• Brand Name: SENSICA UO MONITOR ICU
• Type of Device: SENSICA UO MONITOR ICU
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11429800
• MDR Text Key: 239091074
• Report Number: 1018233-2021-01066
• Device Sequence Number: 1
• Product Code: EXS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

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 Catalogue Number: SCCS1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/07/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other