MAUDE Adverse Event Report: AVANOS MEDICAL, INC. BALLARD; TRAY, SURGICAL, ENT

Lot Number 30120573

Device Problems Melted (1385); No Flow (2991); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2021

Event Type  malfunction  

Event Description

Ballard suction catheter is faulty.1-2 inches of the suction catheter appears to be melted down and nothing is able to pass.

• Brand Name: BALLARD
• Type of Device: TRAY, SURGICAL, ENT
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 13108501
• MDR Text Key: 282911426
• Report Number: 13108501
• Device Sequence Number: 1
• Product Code: MMO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 30120573
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White