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

Model Number 42698

Device Problems Device Dislodged or Dislocated (2923); Unintended Deflation (4061)

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

Event Date 04/01/2021

Event Type  malfunction  

Event Description

We have had 3 g-tube dislodgements in the last couple weeks.Upon assessment of each of the g-tube balloons, the balloon was deflated and would not stay inflated with water or air.All 3 g-tubes were newly placed in the or this year and have the same lot number.

• Brand Name: HALYARD
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11633344
• MDR Text Key: 244399623
• Report Number: 11633344
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2021

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: No Information
• Device Model Number: 42698
• Device Catalogue Number: 8140-12-1.0
• Device Lot Number: 30059154
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1