MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY FCMS URNMTR SIL 16FR 10ML

Catalog Number	URO170816
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "10ml normal saline syringe in the foley kit that snapped off when connected to the connector.We had to use forceps to remove the tip of it.".
Additional Manufacturer Narrative
The customer reported defective saline syringes from the foley kit where the 10 ml normal saline syringe snapped off when connected to the connector, and the tip had to be removed with forceps.Medline quality received 1 ea of the reported product; the product was received in a clear storage bag, used condition.The record does not state a separate confirmation status for the returned product; based on the description of the issue, the root cause is identified as physical weakness at the site of the syringe tip and barrel.This is a known issue identified in medline¿s quality management system, and 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 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: 50867954
• Report Number: 1417592-2026-48650
• Device Sequence Number: 13106366
• Product Code: OHR
• UDI-Device Identifier: 40888277862624
• UDI-Public: 40888277862624
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/22/2026

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: URO170816
• Device Lot Number: 23CBN812
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/18/2023
• 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: 05/05/2023
• Initial Report FDA Received Date: 09/23/2026
• 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