MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TUBE, GASTRIC SUMP, 16FR, 48", 50/CS

Catalog Number	DYND72016
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 "having issues of contents leaking when it¿s connected to kdl771111.".
Additional Manufacturer Narrative
The customer reported having issues of contents leaking when it¿s connected to kdl771111, and according to the facility gastric contents are leaking from the multifunctional port.Medline did not receive the requested product sample for evaluation and was unable to investigate this issue any further.Without the sample to evaluate, medline was unable to confirm the complaint or identify a potential root cause for the reported issue; the cause code was updated to reflect dc: traced to user - knowledge.Medline concluded this is not a medline product quality issue and 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, 16FR, 48", 50/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nathan bersch ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50842457
• Report Number: 1417592-2026-46546
• Device Sequence Number: 13329784
• Product Code: KNT
• UDI-Device Identifier: 40080196036746
• UDI-Public: 40080196036746
• 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): 09/18/2026

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: DYND72016
• Device Lot Number: 23GBG057
• 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: 02/26/2024
• Initial Report FDA Received Date: 09/21/2026
• 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