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

Device Problem Failure to Deliver (2338)

Patient Problems Pain (1994); Missed Dose (2561)

Event Date 04/30/2019

Event Type  malfunction  

Event Description

Pt not receiving dose of pain medication from qball.Troubleshooting occurred and yielded no results.Pt in pain.Qball pulled.Pt care given through the 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: 8658124
• MDR Text Key: 146834946
• Report Number: MW5087022
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR