MAUDE Adverse Event Report: AVANOS MEDICAL, INC. MIC-KEY; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Lot Number 30029867

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 08/08/2020

Event Type  malfunction  

Event Description

Patient's gastrostomy tube dislodged.She was seen in ed and provider placed a 24fr mic-key g-tube into the patient's fistula in her luq of abdomen.No resistance or complication noted.Patient's d/c'd home but presented back to ed later that day d/t her tube falling out.This time the balloon was suspected to still be in her stomach and detached from the tube.Foley cath was placed into ostomy until patient could have tube replaced in ir.Balloon was suspected to have passed through colon since it was not visualized during ir tube placement.Fda safety report id # (b)(4).

• Brand Name: MIC-KEY
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.
• MDR Report Key: 11170052
• MDR Text Key: 227100482
• Report Number: MW5098815
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 30029867
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 51