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

Device Problems Difficult to Flush (1251); Material Deformation (2976); No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 09/13/2021

Event Type  malfunction  

Event Description

Ngt (nasogastric tube) placed, able to withdraw to check ph.Pump alarmed for no flow, new pump obtained and feeding bag obtained.New pump alarmed for no flow.Attempted to flush ngt, unable to flush.Ngt removed and noted to have significant kink.Original packaging discarded, device available.

• Brand Name: CORFLO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12553703
• MDR Text Key: 274053434
• Report Number: 12553703
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 09/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1