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	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a tear in the gastrostomy tube (g-tube) was identified.Reportedly, this tear was located between two of the g-tube ports.When the tear was identified, the g-tube was removed and replaced with a new one.There was no reported impact or adverse effect to the patient.A sample was returned to the manufacturer for evaluation.Inspection of the returned sample confirmed the reported tear.A root cause was not determined.Due to the reported need for medical intervention to remove and replace the g-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 a tear in the gastrostomy tube (g-tube) was identified.

• 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: 8758244
• Report Number: 1417592-2019-00094
• Device Sequence Number: 1690624
• 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
• Report Date (Section B): 07/03/2019

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
• Device Lot Number: (10)S18013779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 07/03/2019
• 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: 66 YR
• Patient Weight: 78