MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TUBE,GASTROSTOMY,22FR,3-PORT,WHITE,1/BX

Catalog Number	DYND70322
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we are experiencing a common issue with the g-tube ports on the medline brand g-tubes prematurely failing and separating from the tube.".
Additional Manufacturer Narrative
The customer reported that the g-tube ports are prematurely failing and separating from the tube.A sample was not received for this complaint, and without a physical sample or picture, this limits the ability to investigate the issue thoroughly and establish a root cause for the reported defect; 6 months of complaint history found no similar complaints related to this product, the vendor was notified of the reported issue, however no response was received, and a review of manufacturing records could not be performed.Due to this, the complaint was not confirmed, and the cause was sample required to determine cause.There was no confirmed medical intervention or serious injury reported related to this incident, and the 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,22FR,3-PORT,WHITE,1/BX
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50890079
• Report Number: 1417592-2026-50578
• Device Sequence Number: 14910268
• Product Code: KNT
• UDI-Device Identifier: 10080196837915
• UDI-Public: 10080196837915
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070124
• 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): 09/24/2026

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: DYND70322
• Device Lot Number: S22004024
• Was Device Available for Evaluation?: Yes
• 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: 08/03/2023
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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