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

Device Problems Component Missing (2306); Material Split, Cut or Torn (4008)

Patient Problem Abscess (1690)

Event Date 08/12/2021

Event Type  malfunction  

Event 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
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES, INC.; 4700 south overland drive; tucson AZ 85714
• MDR Report Key: 12376872
• MDR Text Key: 268479962
• Report Number: 12376872
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00827002356191
• UDI-Public: (01)00827002356191(17)221212(10)1014301
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Weight: 69