MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY FCMS URNMTR SIL 14FR 10ML

Catalog Number	URO170814
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "med surg has reported 3 different instances where the 10ml ns syringe slip-tip has broken off into the male adapter of the balloon fill portal.All 3 times the syringe came from a foley catheter tray.".
Additional Manufacturer Narrative
The customer reported 3 different instances where the 10ml ns syringe slip-tip broke off into the male adapter of the balloon fill portal, and all 3 times the syringe came from a foley catheter tray.Medline quality did not receive a sample nor the lot information of the reported product; medline quality received a sample photograph, and visual assessment of the photo provided shows a 14 fr foley catheter in its packaging wrap, a 10ml syringe filled with sterile water missing its syringe tip, with the syringe tip appearing to be lodged in the balloon inflation port of the 14 fr foley catheter.The reported problem was confirmed based on the photo provided.This is a known issue identified in medline¿s quality management system, and based on the description of the issue, the root cause is identified as physical weakness at the site of the syringe tip and barrel; medline quality will continue to monitor for the issue through weekly complaint meetings and monthly trending analysis.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 FCMS URNMTR SIL 14FR 10ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: juan mota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854043
• Report Number: 1417592-2026-47433
• Device Sequence Number: 21338672
• Product Code: OHR
• UDI-Device Identifier: 40888277866646
• UDI-Public: 40888277866646
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: URO170814
• 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: 07/19/2023
• 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