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

Catalog Number	DYND70318
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the gastrostomy tube balloon burst and was required to be replaced.Despite multiple good-faith attempts, the reporting facility was unable or unwilling to provide additional information to the manufacturer.No impact to the patient's stability was originally reported to the manufacturer.No sample for evaluation was returned to the manufacturer.A root cause for the reported incident could not be determined.Due to the need for medical intervention to replace the gastrostomy tube, 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 balloon burst and was required to be replaced.
Additional Manufacturer Narrative
The manufacturer received communication from the reporting facility.Reportedly, the gastrostomy tube (g-tube) was placed on (b)(6) 2019 and on (b)(6) 2019 the g-tube was identified to be "peeled and broken back." on the date of incident, the g-tube was reportedly removed and replaced.No other information was provided.No sample for evaluation was returned.If additional relevant information becomes available another supplemental medwatch will be filed.

• 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: 8678579
• Report Number: 1417592-2019-00082
• Device Sequence Number: 19410458
• Product Code: KNT
• UDI-Device Identifier: 10080196837908
• UDI-Public: 10080196837908
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: Health Professional
• Device Catalogue Number: DYND70318
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 06/18/2019
• 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: Required Intervention