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

Model Number 13721

Device Problems Defective Component (2292); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2020

Event Type  malfunction  

Event Description

A defective catheter was identified by the surgeon during a procedure.The tip of the catheter detached.No harm came to the patient and this did not cause any delays in the procedure.A new device was used successfully.

• Brand Name: AVANOS ON-Q FIXED FLOW PUMP KITS
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10319520
• MDR Text Key: 200214869
• Report Number: 10319520
• 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: 07/20/2020

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: No Information
• Device Model Number: 13721
• Device Catalogue Number: PM028-A
• Device Lot Number: 101372105
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Weight: 91