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

Catalog Number	DYND150816TS
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there was a leakage in our foley bag.".
Additional Manufacturer Narrative
The customer reported that there was leakage in the foley bag; no patient harm or medical intervention was reported.Medline quality received 1 ea of the reported product in unpackaged, used condition, and visual assessment revealed blue discoloration along the inside of the catheter and drainage funnel and sediment on the tip of the catheter, but not obstructing the catheter; functional testing was then conducted by performing a catheterization simulation.Leakage occurred through a small pinhole at the funnel, verifying the reported issue.A root cause of the pinhole leak at the funnel could not be determined based on the investigation of the sample, and the complaint was closed as unknown responsible party.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: joachim kamanda ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50820971
• Report Number: 1417592-2026-44988
• Device Sequence Number: 13431359
• Product Code: OHR
• UDI-Device Identifier: 40195327149872
• UDI-Public: 40195327149872
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/18/2026

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: DYND150816TS
• Device Lot Number: 592220702
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/04/2024
• 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: 10/28/2024
• Initial Report FDA Received Date: 09/18/2026
• 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