MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION INC. HALYARD; SALINE, VASCULAR ACCESS FLUSH

Model Number	SS010
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Pre-filled syringe was noted to be filled with air instead of saline.

• Brand Name: HALYARD
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION INC.; 9120 lockwood blvd.; mechanicsville VA 23116
• MDR Report Key: 22318020
• Report Number: 22318020
• Device Sequence Number: 21088423
• 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): 06/19/2025
• Report Date (Section F): 06/19/2025

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
• Operator of Device: Health Professional
• Device Model Number: SS010
• Device Lot Number: (10) 24098393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2025
• 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: 06/19/2025