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

Device Problems Break (1069); Complete Blockage (1094)

Patient Problem Insufficient Information (4580)

Event Date 04/29/2022

Event Type  Injury  

Event Description

Patient with clinic visit on (b)(6) 2022 for a clogged ng tube.After unsuccessful attempts to unclog the tube, we removed the tube and discovered that the distal portion of the ng tube was not intact.Fda safety report id# (b)(4).

• Brand Name: AVANOS CORFLO FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 14855540
• MDR Text Key: 295061052
• Report Number: MW5110589
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other