MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD; SALINE, VASCULAR ACCESS FLUSH

Model Number	SS010
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Flush cap found to be melted/deformed after opening packaging.Clear tip of flush also deformed.This is not the first one found.

• Brand Name: HALYARD
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; suite 320; alpharetta GA 30005
• MDR Report Key: 24092930
• Report Number: 24092930
• Device Sequence Number: 16037486
• Product Code: NGT
• UDI-Device Identifier: 10885632389757
• UDI-Public: (01)10885632389757
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2025
• Report Date (Section F): 12/04/2025

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 Model Number: SS010
• Device Catalogue Number: SS010
• Device Lot Number: 25019200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/04/2025