MAUDE Adverse Event Report: C. R. BARD, INC. SENSICA UO SYSTEM; URINOMETER, ELECTRICAL

Model Number SCCS1002

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/11/2022

Event Type  malfunction  

Event Description

Damaged load cell pins (where ring attaches to device), already sent back to manufacturer.

• Brand Name: SENSICA UO SYSTEM
• Type of Device: URINOMETER, ELECTRICAL
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 13666245
• MDR Text Key: 286562246
• Report Number: 13666245
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741215773
• UDI-Public: 00801741215773
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2022

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 Model Number: SCCS1002
• Device Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1