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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

Event Type  No Answer Provided  

Event Description

Patient with on-q pain ball with bolus button.Bolus button locked in bolus position.Med in use was ropivacaine.Outer bag flat/empty with inner ball still palpable.Med surg nurse called pacu nurse to clarify bolus button and was told to "flip off the blue top lock." once that came off bolus button rose back to normal position.Patient states that he did not switch dial overnight.Infusing running at 6 ml/hr upon assessment.No patient harm.Anesthesia providers have been in contact with the company.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH BOLUS
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9362083
• MDR Text Key: 167592709
• Report Number: 9362083
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/18/2019

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?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1