MAUDE Adverse Event Report: AMSINO INTERNATIONAL, INC. AMSAFE ® PRE-FILLED NORMAL SALINE FLUSH SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Model Number	1
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Flush plunger broke off the back while trying to administer medications and spilled.

• Brand Name: AMSAFE ® PRE-FILLED NORMAL SALINE FLUSH SYRINGE
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): AMSINO INTERNATIONAL, INC.; 708 corporate center dr.; pomona CA 91768
• MDR Report Key: 24031472
• Report Number: 24031472
• Device Sequence Number: 10388313
• Product Code: NGT
• UDI-Device Identifier: 30704411015141
• UDI-Public: (01)30704411015141
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2025
• Report Date (Section F): 11/18/2025

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: 1
• Device Catalogue Number: IVF1010TM
• Device Lot Number: 203009TH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2026
• 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: 11/18/2025