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's balloon deflated after insertion.The gastrostomy tube was removed and a new gastrostomy tube was required to be inserted by the physician.No impact or adverse effect to the patient or the patient's stability was reported to the manufacturer.No additional medical intervention or follow-up care was reported to the manufacturer.Reportedly, the gastrostomy tube was discarded after removal.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the need for medical intervention to insert a new 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's balloon deflated after insertion.

• Common Device Name: TUBE,GASTROSTOMY,20FR,3-PORT,WHITE,1/BX
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8150394
• Report Number: 1417592-2018-00131
• Device Sequence Number: 19165831
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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: DYND70320
• Device Lot Number: S18004573
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/11/2018
• 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