MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES; TUBE,GASTROSTOMY,18FR,3-PORT,WHITE,1/BX

Model Number	DYND70318
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported via an email from uplift inc, that a customer's gastrostomy tube balloon was leaking.Reporter states, on tuesday 12/23/2020 at 2:30 am, a replacement gastrostomy tube was placed.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Due to the reported incident, medical intervention 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.Investigation details: 1/6/2021 "we received one used sample of item dynd70318- 18 french 3 port gastrostomy tube from lot# s19006671.Upon initial visual inspection the tube appeared used but in good condition.During investigation, the balloon was inflated with the recommended 15 cc of water.Once inflated the balloon was checked for any sign of leakage however, no leaking was observed.We then over inflated the balloon by 5 cc, filling it with 20 ccs and still no leaking was observed.At this time, the reported complaint of the balloon leaking is not confirmed." divisional qa will continue to monitor and take corrective action as needed.
Event or Problem Description
It is reported; the balloon leaked resulting in a gastrostomy tube replacement.

• Brand Name: MEDLINE INDUSTRIES
• 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: 11166869
• Report Number: 1417592-2020-00164
• Device Sequence Number: 11802944
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2021

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: DYND70318
• Device Catalogue Number: DYND70318
• Device Lot Number: S19006671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/13/2021
• 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