MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HALYARD; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Lot Number 0002994173

Device Problem Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2019

Event Type  malfunction  

Event Description

Halyard corflo safety peg with a connector piece that does not allow the wire to pass through the tube properly.

• Brand Name: HALYARD
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10074489
• MDR Text Key: 191560071
• Report Number: 10074489
• Device Sequence Number: 1
• Product Code: KNT
• 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: 04/22/2020

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: Health Professional
• Device Lot Number: 0002994173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2020
• Date Report to Manufacturer: 05/20/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1