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

Model Number CB002

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/27/2023

Event Type  malfunction  

Event 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.

• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 17641207
• MDR Text Key: 322161634
• Report Number: 17641207
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494134693
• UDI-Public: (01)00193494134693
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Date Report Sent to FDA: 07/11/2023
• Event Location: Home
• Date Report to Manufacturer: 08/29/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1