MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q QBALL; PUMP, INFUSION, ELASTOMERIC

Device Problem Inaccurate Delivery (2339)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/13/2019

Event Type  malfunction  

Event Description

Pt on q ball; not giving medication that was set to give.Pt pain not controlled properly.Q ball discontinued and pt cared for through other avenues.Fda safety report id# (b)(4).

• Brand Name: ON-Q QBALL
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; alpharetta GA 30004
• MDR Report Key: 8658136
• MDR Text Key: 146921619
• Report Number: MW5087023
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR