MAUDE Adverse Event Report: AQUABILITI AQUASTAT; 0.9% SODIUM CHLORIDE FLUSH SYRINGE

Model Number	2T0805
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer returned one 5ml 0.9% sodium chloride flush syringe due to it having one visible particulate inside of the device.The syringe was never used and was returned.A previous identical event of this type was reported in nov of 2024 and the particulate was sent out for analysis.The report indicated it appeared to be consistent with corrugate fibers.

• Brand Name: AQUASTAT
• Common Device Name: 0.9% SODIUM CHLORIDE FLUSH SYRINGE
• Manufacturer (Section D): AQUABILITI; 5209 linbar drive; suite 640; nashville TN 37211
• Manufacturer (Section G): AQUABILITI; 5209 linbar drive; suite 640; nashville TN 37211
• Manufacturer Contact: craig collins ; 5209 linbar drive; suite 640; nashville, TN 37211 ; 6158332633
• MDR Report Key: 22444771
• Report Number: 1000151124-2025-00001
• Device Sequence Number: 8217720
• Product Code: NGT
• UDI-Device Identifier: 00859809005019
• UDI-Public: (01)00859809005019
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K113555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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 Expiration Date: 01/08/2026
• Device Model Number: 2T0805
• Device Lot Number: KH05280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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