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

Device Problem Failure to Deliver (2338)

Patient Problem Pain (1994)

Event Date 05/13/2019

Event Type  malfunction  

Event Description

Qball malfunctioned and did not give dose of medication inside.Troubleshooting completed.Pt still having pain.Removed qball, gave oral meds.Fda safety report id# (b)(4).

• Brand Name: ON-Q BALL
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. ; alpharetta GA 30004
• MDR Report Key: 8658117
• MDR Text Key: 146834179
• Report Number: MW5087021
• 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 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: 82 YR