MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENTUIT THRIVE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE - 20 FR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In radiology, the g-tube was removed from the packaging.Took the tag off of the plug and the plug came off.No harm to patient.

• Brand Name: ENTUIT THRIVE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s overland dr; tucson AZ 85714
• MDR Report Key: 21572599
• Report Number: 21572599
• Device Sequence Number: 8751928
• Product Code: KNT
• UDI-Device Identifier: 00827002356184
• UDI-Public: (01)00827002356184
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/28/2025
• Report Date (Section F): 02/28/2025

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
• Operator of Device: Health Professional
• Device Model Number: ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE - 20 FR
• Device Catalogue Number: 70-0041-220
• Device Lot Number: 11343C001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/28/2025