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

Model Number SCCS1002

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 01/05/2022

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 urine meter was not working on the sensica device.

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 urine meter was not working on the sensica device.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is a damaged load cell due to user improperly removing or attaching the patient ring.The device was evaluated upon receipt.Multiple pins on load cell were bent.The load cell assembly was replaced.Completed final functional testing.The device history record review was not required as the reported event is a use-of-device failure and therefore the reported event is not manufacturing related.The instructions for use were found adequate and state the following: ¿1.4 warnings operation warnings when connecting the single patient use bd sensica¿ ring to the system stand, use a firm, clockwise twisting motion.In order to avoid damaging components, do not apply excessive force or torque to the ring or the system¿s ring interface when connecting the device.Section 2: quick start guide 2.Attach bd sensicatm ring.1.Turn the bd sensicatm ring upside down with hanger facing upward and twist in a clockwise motion to lock into place.Section 5: starting a new patient case 5.3.1 attach ring to attach the bd sensica¿ ring to the stand, orient the ring with the hanger upwards and use a clockwise motion to twist and lock the ring onto the ring interface.Note: in order to avoid damaging components, do not apply excessive force or torque the ring onto the system¿s ring interface when connecting the device.Do not turn the ring counterclockwise when attaching it.Note: do not push down on load cell console or tug/hang on ring as this can damage equipment.Once the bd sensica¿ ring is attached to the system, a green checkmark will appear next to the ¿ring attached¿ step on the monitor session start screen.¿ 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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that urine meter was not working on the sensica device.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13315354
• MDR Text Key: 285409421
• Report Number: 1018233-2022-00158
• 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: 07/12/2022

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 Operator: Health Professional
• Device Model Number: SCCS1002
• Device Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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