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

Model Number SCCS1002

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Date 04/11/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 optical sensor reading "actuated" when a tube was not present on the sensica device.Remains in "actuated" status when reading from utility software.Per review of wo on 19jan2023, there was no patient involvement and date of event occurred was (b)(6) 2023.Per follow up information received via email on 26jan2023, the issue occurred during sensica field action.No patient involvement.Per sample evaluation results received on 11apr2023, it was reported that the upon receipt, there was a dent on front interface housing.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be that user does not know how to properly pick up system.However, this cannot be confirmed.The device was evaluated upon receipt.Dent on front interface housing.No repairs were made towards the dent on the interface housing.The device did not meet specifications, and was influenced by the reported failure.The device was not in use on a patient.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: general warnings: medical electrical equipment requires special precautions regarding electromagnetic compatibility (emc) and needs to be installed and put into service according to the emc information provided in the charts at the end of these instructions for use (appendix a).Portable and mobile radiofrequency (rf) communications equipment can affect medical electrical equipment.The bd sensica¿ urine output system should not be stacked with other equipment.The bd sensica¿ urine output system has a degree of protection against electric shock of applied parts classified as type bf.This device is classified as an iec class i device.When using class 1 xp power model number: alm65us12 power supply, to avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.Do not immerse or submerge the bd sensica¿ urine output stand, display monitor, ring, temperature monitor module, temperature sensor cables, or monoplug adapter in water or other liquids.Do not pour liquids over the display monitor, ring, temperature monitor, cables or monoplug adapter.If liquids accidentally spill onto the device(s), wipe off liquid with soft cloth as soon as possible.See section 14 for complete care instructions.This device is not suitable for use in the presence of flammable mixtures.This device is not suitable for use in oxygen rich environments.The use of transducers and cables other than those specified, with the exception of transducers and cables sold as replacement parts, may result in increased emissions or decreased immunity of the bd sensica¿ urine output system.The bd sensica¿ urine output system is designed to be used with any bard¿ foley catheter and urological disposables connected to any standard urine drainage bag (2000 or 2500 ml), with or without a urine meter.If using a 400-series temperature-sensing foley catheter, see product instructions for use for mri compatibility.Refer to foley catheter instructions for use for indications and further product information.If using a 400-series temperature-sensing foley catheter, the operator is responsible for ensuring the compatibility of the temperature sensing foley catheter to the bd sensica¿ urine output system and its accessories.Incompatible components can result in degraded performance.No modification of the bd sensica¿ urine output system or any of its accessories is allowed.Warning: this product can expose you to di(2-ethylhexyl) phthalate (dehp), which is known to the state of california to cause cancer and birth defects or other reproductive harm.¿ h11: section a through f - the information provided by bd represents all 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 evaluated.

Event Description

It was reported that the optical sensor reading "actuated" when a tube was not present on the sensica device.Remains in "actuated" status when reading from utility software.Per review of wo on 19jan2023, there was no patient involvement and date of event occurred was 16jan2023.Per follow up information received via email on 26jan2023, the issue occurred during sensica field action.No patient involvement.Per sample evaluation results received on 11apr2023, it was reported that the upon receipt, there was a dent on front interface housing.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.H11: section a through f - the information provided by bd represents all 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 optical sensor reading "actuated" when a tube was not present on the sensica device.Remains in "actuated" status when reading from utility software.Per review of wo on 19jan2023, there was no patient involvement and date of event occurred was (b)(6) 2023.Per follow up information received via email on 26jan2023, the issue occurred during sensica field action.No patient involvement.Per sample evaluation results received on 11apr2023, it was reported that the upon receipt, there was a dent on front interface housing.

• Brand Name: SENSICA UO SYSTEM
• Type of Device: SENSICA UO SYSTEM
• 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: 16867388
• MDR Text Key: 314538364
• Report Number: 1018233-2023-03112
• 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,Followup
• Report Date: 07/20/2023

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: 02/08/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 05/25/2023; 07/20/2023
• Supplement Dates FDA Received: 05/31/2023; 08/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2021
• 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