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

Model Number	ENTUITTM THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE - 22 FR
Health Effect - Clinical Code	Abscess (1690)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient presented to emergency department from skilled nursing facility with lumbar abscess and poor nutrition.Prior to the placement (insertion) of an entuit thrive gastrostomy tube, examination by the health care providers found that the end of the device (non-feed hub) was torn off and missing.Another gastrostomy tube was used for the procedure.Please note that packaging for this device was not saved.The lot number provided in the picture is representation for what was used, they were next to each other on the stocked shelf.

• Brand Name: ENTUIT THRIVE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES, INC.; 4700 south overland drive; tucson AZ 85714
• MDR Report Key: 12376872
• Report Number: 12376872
• Device Sequence Number: 14437873
• Product Code: KNT
• UDI-Device Identifier: 00827002356191
• UDI-Public: (01)00827002356191(17)221212(10)1014301
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/18/2021
• Report Date (Section F): 08/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: ENTUITTM THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE - 22 FR
• Device Catalogue Number: 70-0041-222
• Device Lot Number: 1014301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 69
• Date Report Sent to FDA: 08/18/2021