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

Model Number	DYND70320
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the patient's gastrostomy tube was inserted on (b)(6) 2020 however the tube deflated and fell out on (b)(6) 2020.According to the nurse, she could clearly see the balloon was torn.After the incident the nurse reported that the clinician put in a new gastrostomy tube without further incident noted.One used sample was returned for evaluation and the customer reported issue was not confirmed.The balloon was inflated with ease with 15cc of water and no leaks or tears in the balloon were noted.The root cause of the customer reported issue could not be determined.No additional information is available.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
The patient's gastrostomy tube deflated while still inserted and fell out requiring insertion of a new gastrostomy tube.

• Brand Name: MEDLINE INDUSTRIES
• Common Device Name: TUBE,GASTROSTOMY,20FR,3-PORT,WHITE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10774623
• Report Number: 1417592-2020-00118
• Device Sequence Number: 19869043
• Product Code: KNT
• UDI-Device Identifier: 10080196837922
• UDI-Public: 10080196837922
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/02/2020

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 Model Number: DYND70320
• Device Catalogue Number: DYND70320
• Device Lot Number: S19006258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/02/2020
• 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: 68 YR
• Patient Weight: 55