MAUDE Adverse Event Report: AVANOS MEDICAL, INC. MIC-KEY SF GASTROSTOMY FEEDING TUBE, LOW-PROFILE G-TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number BAA01201212

Device Problems Deflation Problem (1149); Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 09/11/2021

Event Type  malfunction  

Event Description

Accidental mickey button g-tube dislodgement in the pcicu (pediatric cardiac intensive care unit) on wednesday evening.The button was only about a week old at the time of dislodgement and was noted to have a deflated balloon when it was dislodged.On further investigation, there appears to me a minor slit in the balloon.Manufacturer response for g-tube, mic-key button g-tube (per site reporter): notified avanos.They sent a mailer and rga which were received.Item was shipped two days later via (b)(6) and they sent a replacement product to the unit.

• Brand Name: MIC-KEY SF GASTROSTOMY FEEDING TUBE, LOW-PROFILE G-TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12466906
• MDR Text Key: 271260749
• Report Number: 12466906
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BAA01201212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other