MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TUBE,GASTROSTOMY,18FR,3-PORT,WHITE,1/BX

Catalog Number	DYND70318
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that after being inserted for approximately 1-2 weeks, the gastrostomy (g-tube) balloon "popped" during feeding.Reportedly, the g-tube was taken out to "sterilize it with alcohol" and then it was "tape[d] back in." following an unidentified period of time after this incident, the g-tube was reportedly removed.There was no impact or adverse effect to the end-user.No medical intervention or follow-up care was reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the gastrostomy tube (g-tube) balloon "popped" and the g-tube was removed.

• Common Device Name: TUBE,GASTROSTOMY,18FR,3-PORT,WHITE,1/BX
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8807658
• Report Number: 1417592-2019-00118
• Device Sequence Number: 19548007
• Product Code: KNT
• UDI-Device Identifier: 10080196837908
• UDI-Public: 10080196837908
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2019

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: Lay User/Patient
• Device Catalogue Number: DYND70318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/19/2019
• 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: Other; Required Intervention