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

Model Number 13701

Patient Problem Insufficient Information (4580)

Event Date 10/04/2023

Event Type  Other  

Event Description

During the patient's visit with the provider, it was discovered that the pump did not function and the medication in the pump did not go into the patient.The clip was not closed off and there were no visible issues with the pump.The medication was still present in the bulb portion of the pump.

• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 18028749
• MDR Text Key: 326838718
• Report Number: 18028749
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2023

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 Model Number: 13701
• Device Catalogue Number: PM012-A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/12/2023
• Date Report to Manufacturer: 10/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA