MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TUBE,GASTROSTOMY,20FR,3-PORT,WHITE,1/BX

Catalog Number	DYND70320
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the gastrostomy tube was inserted (b)(6) 2018 wherein the balloon was inflated to 10 cc and the external bumper was made appropriately snug with the external mark at 3cm.Per report, on (b)(6) 2018, the gastrostomy tube's balloon broke resulting in the gastrostomy tube falling out from the patient.The gastrostomy tube was subsequently replaced.Due to the reported incident, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the gastrostomy tube's balloon broke and was subsequently replaced.

• Common Device Name: TUBE,GASTROSTOMY,20FR,3-PORT,WHITE,1/BX
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8221854
• Report Number: 1417592-2018-00148
• Device Sequence Number: 18901319
• Product Code: KNT
• UDI-Device Identifier: 10080196837922
• UDI-Public: 10080196837922
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2019

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: Health Professional
• Device Catalogue Number: DYND70320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 01/07/2019
• 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
• Patient Age: 71 YR
• Patient Weight: 82