MAUDE Adverse Event Report: Medline Industries LP Medline; LHK - OCHSNER BAPTIST MED

Catalog Number	VASC1424
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the syringe is breaking off the manifold system.
Additional Manufacturer Narrative
It was reported that when the physicians are injecting contrast or saline the syringe is breaking off the manifold system.The leur lock is still screwed into the manifold system.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.

• Brand Name: Medline
• Common Device Name: LHK - OCHSNER BAPTIST MED
• Manufacturer (Section D): Medline Industries LP; three lakes dr; northfield; northfield IL 60093
• Manufacturer Contact: michael crook ; three lakes dr; northfield, IL 60093
• MDR Report Key: 50872201
• Report Number: 1417592-2026-49267
• Device Sequence Number: 13089797
• Product Code: OES
• UDI-Device Identifier: 10195327417475
• UDI-Public: 10195327417475
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: VASC1424
• Device Lot Number: 26DBT619
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown