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	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by the facility that the balloon in the gastrostomy tube deflated and the gastrostomy tube fell out of the patient requiring the patient to go to the emergency department and have the gastrostomy tube replaced.According to the facility the gastrostomy tube was placed by a gastroenterologist in the emergency department of the local hospital on (b)(6) 2019 and maintained by a staff nurse at the facility.The facility reported that the balloon of the gastrostomy tube is checked at unspecified intervals by the staff nurse to verify there is 15cc of sterile water in the balloon to ensure the tube maintains stability in the patient; however on 10/4/2019 the nurse noted that the balloon did not have 15cc of sterile water inside the balloon during her routine check, the balloon was deflating, but the tube did not fall out of the patient.The nurse was able to inflate the balloon without further incident.On 10/07/2019 the patient care tech found the balloon deflated and the tube fell out of the patient.The tech called the nurse and after the patient assessment was complete it was noted that the balloon was deflated.The patient did not have any tubes at the facility to replace the current tube, so the facility sent the patient to the hospital to have the gastrostomy tube replaced.There was no further incident reported related to the gastrostomy tube placement.The facility reported that there was no serious injury or follow up treatment required related to the customer reported issue.There was no impact to the patient or the patient's plan of care.The patient did not miss any feedings or hydration related to the incident.No additional information is available.The sample was discarded and is not available to be returned to the manufacturer for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported by the facility that balloon in the gastrostomy tube deflated and gastrostomy tube fell out of the patient requiring the gastrostomy tube to be replaced.

• Common Device Name: TUBE,GASTROSTOMY,18FR,3-PORT,WHITE,1/BX
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9213160
• Report Number: 1417592-2019-00183
• Device Sequence Number: 2659978
• Product Code: KNT
• UDI-Device Identifier: 10080196837908
• UDI-Public: 10080196837908
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/21/2019

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/21/2019
• 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: 55 YR
• Patient Weight: 104