MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY FOLEY 100%SILI L/F 1

Catalog Number	DYND11519
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the catheter is increasingly hard to pull out of the tubing if the catheter were needed to be replaced.".
Additional Manufacturer Narrative
Medline quality received a complaint regarding difficulty disconnecting a foley catheter from its drainage bag tubing; the complaint transcript stated that the catheter is increasingly hard to pull out of the tubing if the catheter were needed to be replaced.Medline quality did not receive a sample nor photographs of the reported product, and a retrospective review of the reported issue revealed no additional complaints of disconnection issues with respect to the reported product.The reported issue could not be confirmed as no sample nor photographs were received to investigate, and a root cause cannot be identified at this time.Due to the inability to confirm the complaint, as well as the low reported occurrence rate, no further corrective action is necessary at this time, and medline quality will continue to monitor for this complaint through bi-weekly complaint meetings and quarterly trending analysis.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: TRAY FOLEY 100%SILI L/F 1
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50714368
• Report Number: 1417592-2026-35700
• Device Sequence Number: 10611607
• Product Code: OHR
• UDI-Device Identifier: 40080196809791
• UDI-Public: 40080196809791
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K082815
• 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): 09/05/2026

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: DYND11519
• Device Lot Number: 96922060001
• 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: 01/31/2023
• Initial Report FDA Received Date: 09/10/2026
• 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