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

Catalog Number	SCCS1002
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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 or Problem Description
It was reported that the sensica device displayed 4am as the previous hour even though it was nearly 10am there on the clock.Only the total volume was displayed and the output from 4am on was being displayed under current hour.They stated that the original nurse that reported this removed the bag from the ring first to clean the patient and after returning the bag the previous hour never changed to the next hour and stayed at 4am.Nurse originally reported at 4am.Per review of wo notes on 18aug2025, that issue occurred during the bag removal and return process.Customer could not confirm if the bag was moved or removed during the stabilization process.Nurse will start a new session and call back if the issue returns.
Additional Manufacturer Narrative
The reported issue was inconclusive.Root cause was not able to be isolated as unit was not evaluated.Only the total volume was displayed and the output from 4am on was being displayed under current hour.They stated that the original nurse that reported this removed the bag from the ring first to clean the patient and after returning the bag the previous hour never changed to the next hour and stayed at 4am.Nurse originally reported at 4am.Per wo review, that issue occurred during the bag removal and return process.Customer could not confirm if the bag was moved or removed during the stabilization process.Nurse will start a new session and call back if the issue returns.The instructions-for-use are found to be adequate.The ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions can be taken.Correction: d.Udi format updated with available product information per gudid.H11: sections 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 or Problem Description
It was reported that the sensica device displayed 4am as the previous hour even though it was nearly 10am there on the clock.Only the total volume was displayed and the output from 4am on was being displayed under current hour.They stated that the original nurse that reported this removed the bag from the ring first to clean the patient and after returning the bag the previous hour never changed to the next hour and stayed at 4am.Nurse originally reported at 4am.Per review of wo notes on 18aug2025, that issue occurred during the bag removal and return process.Customer could not confirm if the bag was moved or removed during the stabilization process.Nurse will start a new session and call back if the issue returns.

• Brand Name: SENSICA UO SYSTEM
• Common Device Name: SENSICA
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22860922
• Report Number: 1018233-2025-06929
• Device Sequence Number: 9230925
• Product Code: EXS
• UDI-Device Identifier: 00801741215773
• UDI-Public: (01)00801741215773(11)211001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown