MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q* C-BLOC PAIN RELIEF SYSTEM; PUMP, INFUSION, ELASTOMERIC

Model Number	CB002
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient reported severe pain all night and did not think on-q pump was working.Patient did not see any kinks in the tubing and the tubing is not clamped.Had patient disconnect the tubing from the catheter with help from the family and they did not see anything dripping from the end of the on-q tubing.On-q pump has not decreased in size since connection yesterday.Patient was instructed to remove the nerve catheter and report her lack of pain control to her surgical team.

• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 17641207
• Report Number: 17641207
• Device Sequence Number: 12746771
• Product Code: MEB
• UDI-Device Identifier: 00193494134693
• UDI-Public: (01)00193494134693
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2023
• Report Date (Section F): 07/11/2023

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 Model Number: CB002
• Device Catalogue Number: CB002
• Device Lot Number: QS-33788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 08/29/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/11/2023