MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q C-BLOC WITH SELECT-A-FLOW AND ONDEMAND; ELASTOMERIC - COMBO

Model Number	CB006
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and the investigation remains in progress at this time.A review of the device history record and udi are in-progress.All information reasonably known as of 11 apr 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.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 avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
Event or Problem Description
Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving one patient.This is the second of two reports.Fill volume: 545 ml, flow rate: unknown, procedure: unknown, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.It was reported, ¿a patient was continuing to hold the bolus button down and when instructed to release it stayed in the locked position.The account has some concerns that the bolus button can be held and continue to deliver a higher/ lower volume (not a true lockout) than the 5ml/ 30 min.Confirmed with the account that the bolus is ready every 30 min when the orange line indicator is at the top of the side window.¿ per note received with sample return on 26mar2025, ¿on demand control not locking patient out.Able to give does, then give again.I pushed it when not connected to patient and it bloused around 3-5 ml 10 minutes after last does.Patient got approximately 10ml bolus within 45 minutes.¿.
Additional Manufacturer Narrative
Additional information: d4, h4, h6, h11 the device history record for lot 30327213 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.During the evaluation the bolus button functioned as intended, results met specifications and there were no issues such as leakage or breakage on the component.The incident was not confirmed.A root cause could not be determined.All information reasonably known as of 25 jul 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.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 avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: ON-Q C-BLOC WITH SELECT-A-FLOW AND ONDEMAND
• Common Device Name: ELASTOMERIC - COMBO
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c.
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 21830455
• Report Number: 2026095-2025-00008
• Device Sequence Number: 11814820
• Product Code: MEB
• UDI-Device Identifier: 00193494134747
• UDI-Public: (01)00193494134747(240)120001124(17)260926(10)30327213
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: Lay User/Patient
• Device Expiration Date: 09/26/2026
• Device Model Number: CB006
• Device Catalogue Number: CB006
• Device Lot Number: 30327213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROPIVACAINE HCL 0.2%.
• Patient Sex: Unknown