MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE; GASTROSTOMY TUBE

Model Number 70-0041-116

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Manufacturer Narrative

No patient information was available other than stated patient outcome under event description.Model number is xeridiem's part number for the device.Catalog number is part number for xeridiem's exclusive distributor for the device, (b)(4).Device was not returned for evaluation.Since lot number is not available, manufacturing date could not be determined.Patient code and device code reflect what was reported in the complaint.Other codes are chosen based on the device not being returned for evaluation.

Event Description

Three days after percutaneous placement the balloon deflated.It was replaced with another sbrd-16.Patient outcome: peritonitis.

• Brand Name: ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE
• Type of Device: GASTROSTOMY TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• Manufacturer (Section G): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• Manufacturer Contact: steve murray ; 4700 s. overland drive; tucson, AZ 85714-3430 ; 5208827794
• MDR Report Key: 7527937
• MDR Text Key: 108720557
• Report Number: 2025851-2018-00001
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K130611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70-0041-116
• Device Catalogue Number: SBRD-16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention