MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE 3-PORT GASTROSTOMY TUBE WITH ENFIT CONNECTOR, 16 FR, 5 ML BALLOON; TUBE,GASTROSTOMY,16FR,3-PORT,ENFIT

Catalog Number	ENFIT70316
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 the patient's gastric tub had come out, and it was discovered that there was a "pin hole leak" in the balloon.The customer reported the defective product was re-inserted and "anchored using tape and a binder until a new one can arrive".The customer reported a new tube will be inserted when a replacement is available.The customer reported there was no serious injury related to the reported incident.No additional details are available related to the customer reported issue.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, on (b)(6) 2025 the patient's gastric tub had come out, and it was discovered that there was a "pin hole leak" in the balloon.

• Brand Name: MEDLINE 3-PORT GASTROSTOMY TUBE WITH ENFIT CONNECTOR, 16 FR, 5 ML BALLOON
• Common Device Name: TUBE,GASTROSTOMY,16FR,3-PORT,ENFIT
• 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: 23907250
• Report Number: 1417592-2025-00745
• Device Sequence Number: 13034842
• Product Code: PIF
• UDI-Device Identifier: 10888277411043
• UDI-Public: 10888277411043
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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: ENFIT70316
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 63 KG