MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TUBE, GASTRIC SUMP, 18FR, 48", 50/CS

Catalog Number	DYND72018
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when attaching the tube to the multifunctional port made from covidien it is leaking gastric contents.
Additional Manufacturer Narrative
According to the facility, gastric contents are leaking from the multifunctional port; per the facility no injury occurred, no medical intervention was required, and there was no impact to the patient/user.A sample was received and assigned to qa tech, and the investigation stated that this is not a medline product quality issue because the adaptor in conjunction with the gastric sump tube is not an exact cross.The complaint record does not state that the reported leaking was confirmed through product evaluation.The cause code was updated to reflect dc: traced to user - knowledge, and the overall conclusion was that the reported concern was not a quality issue.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, GASTRIC SUMP, 18FR, 48", 50/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50855423
• Report Number: 1417592-2026-47709
• Device Sequence Number: 21220919
• Product Code: KNT
• UDI-Device Identifier: 40080196036760
• UDI-Public: 40080196036760
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K810156
• 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): 09/21/2026

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: DYND72018
• Device Lot Number: 23JBL073
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/01/2024
• 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: 02/26/2024
• 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