MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) AVANOS MIC G-J FEEDING TUBE WITH ENFIT CONNECTORS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 8250-22

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Description

We have had a couple of patients who have required more frequent tube replacements than normal.These patients both have avanos brand enfit gtube or gjtubes.Additional device information provided below.Lot 30211447.Ref 8250-22; lot 30213424, ref 8250-22; lot 301476558, ref 8250-22; lot 30147658, ref 8250-22; lot 30175803, ref 8100-20; lot 30122663, ref 8100-20; lot 30185787, ref 8100-20; lot 30113520, ref 8100-20; lot 30167456, ref 8100-20.

• Brand Name: AVANOS MIC G-J FEEDING TUBE WITH ENFIT CONNECTORS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 16253941
• MDR Text Key: 308441795
• Report Number: MW5114528
• Device Sequence Number: 6
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/24/2023
• 9 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 8250-22
• Device Lot Number: 30211447
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1