MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 1LYRTR 16FR10ML LATEX DB SNAP

Catalog Number	URO175116H
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "drain bag leaking at seams.".
Additional Manufacturer Narrative
The customer reported a drain bag leaking at seams; the lower right hand corner near the drainage port is where the leaking came from, no patient harm was done, and no medical intervention was necessary.Medline quality received 1 ea of the reported product in unpackaged, unused condition; visual assessment revealed no defects nor abnormalities, and functional testing was conducted by filling the drainage bag and inspecting for leakage.The reported issue of leakage could not be verified based on visual or functional inspection of the received sample.Based on the description of the issue, some possible root causes could be, but are not limited to, external damage, valve closure, or an unobserved manufacturing defect; due to the inability to confirm the complaint, as well as the low reported occurrence rate of this issue, no further corrective action is necessary at this time.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: 1LYRTR 16FR10ML LATEX DB SNAP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50806190
• Report Number: 1417592-2026-43911
• Device Sequence Number: 10611105
• Product Code: OHR
• UDI-Device Identifier: 10193489987294
• UDI-Public: 10193489987294
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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): 09/17/2026

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: URO175116H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/07/2023
• 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: 11/29/2023
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (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