MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY FOL TEMP UM 16FR 10ML MF

Catalog Number	DYND150816TS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "leaking around foley catheter noted" and "a few hours later, it was noted to be leaking again.".
Additional Manufacturer Narrative
The facility reported the foley catheter was leaking; the registered nurse attempted to reposition the foley, however, it began leaking again, and the foley catheter was removed and was not replaced.Medline quality received 1 ea of the reported product in unpackaged, used condition; visual assessment revealed no defects nor abnormalities, dimensional analysis of the catheter found no issues, and functional testing in the catheterization simulator found the catheter drained 300 ml of simulated urine without incident, the retention balloon inflated without issue, and no leakage nor flow issues were observed.The reported issue could not be verified based on visual or functional inspection of the received sample; possible root causes could be, but are not limited to, catheter placement, patient positioning, patient anatomy/physiology, or bladder spasm.There are currently no known trends for this product lot, medline quality will continue to monitor for the issue through bi-weekly complaint meetings and quarterly trending analysis, and no further action is needed 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: TRAY FOL TEMP UM 16FR 10ML MF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50691449
• Report Number: 1417592-2026-34703
• Device Sequence Number: 14946229
• Product Code: OHR
• UDI-Device Identifier: 40195327149872
• UDI-Public: 40195327149872
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 09/04/2026

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: DYND150816TS
• Device Lot Number: 23KBT555
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2024
• 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: 03/18/2024
• Initial Report FDA Received Date: 09/09/2026
• 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