MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries; TUBE,GASTROSTOMY,16FR,3-PORT,WHITE,1/BX

Model Number	DYND70316
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the gastrostomy tube "cracked on the top where it was leaking".The customer reported the tube was replaced in the home under "sterile technique".The customer reported "there was no harm that came to the patient".The customer reported she discarded the gastrostomy tube after replacing it.No medical intervention, serious injury, or follow-up care has been reported.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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
According to the customer, the gastrostomy tube "cracked on the top where it was leaking".

• Brand Name: Medline Industries
• Common Device Name: TUBE,GASTROSTOMY,16FR,3-PORT,WHITE,1/BX
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17301458
• Report Number: 1417592-2023-00283
• Device Sequence Number: 3715778
• Product Code: KNT
• UDI-Device Identifier: 10080196837892
• UDI-Public: 10080196837892
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DYND70316
• Device Catalogue Number: DYND70316
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown