MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) CORFLOW ENTERAL FEEDING CATHETER; TUBE, FEEDING

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2021

Event Type  malfunction  

Event Description

Ng tube placed in patient, x-ray confirmation done, tube feeds started.Upon tube feeds being started leaking was noted.Nursing inspected tube and found a hole in the tube.Tube was removed and new ng tube was placed.The buyer was contacted who will be following up with the manufacturer and distributor to report this.Fda safety report id# (b)(4).

• Brand Name: CORFLOW ENTERAL FEEDING CATHETER
• Type of Device: TUBE, FEEDING
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 11398550
• MDR Text Key: 234480318
• Report Number: MW5099715
• Device Sequence Number: 1
• Product Code: FPD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR