MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) ON-Q PUMP; PUMP, INFUSION, ELASTOMERIC

Lot Number 20002966

Device Problem Leak/Splash (1354)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/27/2020

Event Type  malfunction  

Event Description

On q pump reported leaking by the patient's mother after discharge.Poor pain control reported with a need in treatment escalation.Mother reported event to manufacturer but did not receive a response regarding her concerns with the pump "leaking." mother reported difficulty navigating the manufacturer website to file the report.This report is being filed in response to a annual follow-up post therapy.Device was retained by patient's mother and is available for review.Fda safety report id#: (b)(4).

• Brand Name: ON-Q PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 11574535
• MDR Text Key: 242792426
• Report Number: MW5100290
• Device Sequence Number: 1
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 20002966
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1