MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TUBE,GASTROSTOMY,20FR,3-PORT,ENFIT

Catalog Number	ENFIT70320
Medical Device Problem Codes	Crack (1135); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the tubing that is inserted into the stomach cracked on two separate occasions.".
Additional Manufacturer Narrative
A complaint was received regarding cracked gastrostomy tubes; per the customer, the reported issue was discovered prior to use and has happened on two separate occasions.A sample was provided by the customer, the vendor was notified of the issue and sent the form along with the sample received, and the vendor¿s review of the production processes and relevant records noted that there were no nonconformities during the manufacture of this product lot; the vendor noted that the returned sample showed obvious signs of use as it was filled with fluid and the crack was noted to be a jagged tear rather than a clean cut, pointing to possible user error.Based on the information provided and the results of the investigation, the reported issue was confirmed; however, the vendor was unable to determine that the issue was related to the manufacture of the product, and neither a root cause nor a systematic trend could be identified.No corrective actions have been warranted at this time, and a divisional quality representative will continue to monitor this issue for tracking and trending purposes during quarterly trending.There were no reports of death, serious injury, medical intervention, or follow up care.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: TUBE,GASTROSTOMY,20FR,3-PORT,ENFIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: juan mota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854304
• Report Number: 1417592-2026-47489
• Device Sequence Number: 15959148
• Product Code: PIF
• UDI-Device Identifier: 10888277411067
• UDI-Public: 10888277411067
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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
• Device Catalogue Number: ENFIT70320
• Device Lot Number: 1122502
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown