MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TUBE,GASTROSTOMY, 22FR, 3-PORT, ENFIT

Catalog Number	ENFIT70322
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the customer had a feeding tube put in (b)(6) 2016 (from an alternate manufacturer) that required replacement in (b)(6) 2017 due to the stopper on the tube cracking.The customer reported that the tube was replaced and the patient was discharged.A week later the customer's wife was checking the residual and extracted coffee ground residual.The customer was taken to the hospital and underwent an esophagogastroduodenoscopy (egd) procedure where the surgeon discovered a gastric ulcer.According to the customer's wife the balloon that holds the percutaneous endoscopic gastrostomy (peg) tube in place was not inflated and was rubbing against the gastric mucosa which caused an ulcer.The peg tube was replaced with a different tube without further incident.Due to the reported incident and subsequent need for medical intervention, this medwatch is being filed.The sample related to the incident was discarded and is not available for evaluation.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a gastrostomy tube retention balloon deflated and needed to be replaced.

• Common Device Name: TUBE,GASTROSTOMY, 22FR, 3-PORT, ENFIT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7046366
• Report Number: 1417592-2017-00076
• Device Sequence Number: 19369330
• Product Code: KNT
• UDI-Device Identifier: 10888277411074
• UDI-Public: 10888277411074
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: ENFIT70322
• Device Lot Number: 94505
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention