MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) AVANOS INTRODUCER KIT FOR GASTRIC-JEJUNAL FEEDING TUBE; TUBE, GASTRO-ENTEROSTOMY

Lot Number 30152469

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/12/2021

Event Type  malfunction  

Event Description

During a gastrostomy tube placement procedure, the telescoping inner plastic dilator propagated forward and a single portion was retained.The retained portion was retrieved.Fda safety report id# (b)(4).

• Brand Name: AVANOS INTRODUCER KIT FOR GASTRIC-JEJUNAL FEEDING TUBE
• Type of Device: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 12868742
• MDR Text Key: 281286901
• Report Number: MW5105541
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2023
• Device Lot Number: 30152469
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male