MAUDE Adverse Event Report: Avanos Medical Inc. ON-Q C-Bloc with SELECT-A-FLOW and ONDEMAND; Pump, Infusion, Elastomeric

Model Number	13473
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury

• Brand Name: ON-Q C-Bloc with SELECT-A-FLOW and ONDEMAND
• Common Device Name: Pump, Infusion, Elastomeric
• 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. 22116 ; MX 22116
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; +1(470)448-5487
• MDR Report Key: 50543580
• Report Number: 2026095-2026-00074
• Device Sequence Number: 10600896
• Product Code: MEB
• UDI-Device Identifier: 00193494134730
• UDI-Public: (01)00193494134730(240)12000305(11)250305(17)270305(10)30354907
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 13473
• Device Catalogue Number: CB005
• Device Lot Number: 30354907
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male