MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY,FOLEY,SIL,16FR,10ML,W/SD

Catalog Number	DYND150716
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "med port pulling out when used" and "the med port spins and then is pulled out.".
Additional Manufacturer Narrative
The customer reported multiple foley catheters "are having issues with the med port pulling out when used," and that when a syringe is screwed onto the port, "the med port spins and then is pulled out." medline quality did not receive a sample nor photographs of the reported product; a review of the inspection record for the reported item found no similar issues reported, and a post-market retrospective review of the past 24 months revealed 0 additional complaints of sample port detachment with respect to (b)(6).It was reported that the issue occurred during bladder instillation of bcg through the sample port valve, and bladder instillation with bcg and chemotherapy drugs is off-label use for this product.Due to the reported issue occurring during off-label use of the product and a sample/pictures being unavailable for review, the issue cannot be confirmed as a product defect, and a root cause cannot be identified 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,FOLEY,SIL,16FR,10ML,W/SD
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50852501
• Report Number: 1417592-2026-47247
• Device Sequence Number: 9935939
• Product Code: OHR
• UDI-Device Identifier: 10195327035129
• UDI-Public: 10195327035129
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/21/2026

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: DYND150716
• Device Lot Number: 24EBU052
• 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: 02/26/2025
• Initial Report FDA Received Date: 09/22/2026
• 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