MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY,FOLEY CATH,SIL-ELAST,NO BG,16FR10ML

Catalog Number	DYND10150H
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon on catheter is deflating on monday.It is possible that the previous catheter also fell out after 5 weeks.
Additional Manufacturer Narrative
The case manager reported that the balloon on catheter was deflating, and it was possible that the previous catheter also fell out after 5 weeks.Medline quality did not receive a sample nor photographs of the reported product, and a post-market retrospective review of the past 6 months preceding the reported issue revealed 0 additional complaints of catheters deflating with respect to this product.The issue is unconfirmed, as no samples nor photographs were made available to review, and a root cause cannot be identified at this time.Based on the findings of the quality investigation, no change has been made to the regulatory reportability decision for the complaint.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 CATH,SIL-ELAST,NO BG,16FR10ML
• 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: 50774335
• Report Number: 1417592-2026-40692
• Device Sequence Number: 13396374
• Product Code: OHR
• UDI-Device Identifier: 10080196028498
• UDI-Public: 10080196028498
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/14/2026

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: DYND10150H
• Was Device Available for Evaluation?: No
• 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: 12/05/2024
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown