MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY FOLEY 100% SIL 16FR 10ML

Catalog Number	DYND11523
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we had two of these, that the balloon didn¿t work".
Additional Manufacturer Narrative
Medline quality received a complaint regarding balloon failures; the customer reported, "we had two of these, that the balloon didn¿t work and had to be tossed." medline quality did not receive a sample nor photographs of the reported product; review of the device history record revealed 0 similar reported issues, and a retrospective review of the past 6 months preceding the reported issue revealed 1 additional complaint of balloon defects.The issue is unconfirmed, as no samples nor photographs were made available to review, and a root cause cannot be identified at this time.Medline quality will continue to monitor for the issue through weekly complaint meetings and monthly trending analysis; if a product is received or more information is made available, the complaint will be reopened and an investigation will be performed.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% SIL 16FR 10ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50819831
• Report Number: 1417592-2026-44812
• Device Sequence Number: 13312412
• Product Code: OHR
• UDI-Device Identifier: 40884389497297
• UDI-Public: 40884389497297
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/17/2026

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: DYND11523
• Device Lot Number: 23LBL066
• 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: 03/22/2024
• Initial Report FDA Received Date: 09/18/2026
• 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