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

Model Number	2T0806
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Aquabiliti produces saline filled syringes using purchased components (saline, syringes, and tip caps).An independent test lab identified the foreign material as recycle paper pulp and trace components of cailcite and kaolinite.The manner in which the material entered the syringe is unknown, as the syringes are filled in a clean room void of such materials.
Event or Problem Description
Distributor returned one unused 10ml 09% soduium chloride flush syringe due to it having a black spec inside of the device.

• Brand Name: AQUASTAT
• Common Device Name: 0.9% SODIUM CHLORIDE FLUSH SYRINGE
• Manufacturer (Section D): AQUABILITY; 5209 linbar drive; suite 640; nashville TN 37211
• Manufacturer (Section G): AQUABILITI; 5209 linbar drive; suite 640; nashville TN 37211
• Manufacturer Contact: jay davis ; 5209 linbar drive; suite 640; nashville, TN 37211 ; 6158332633
• MDR Report Key: 20893590
• Report Number: 1000151124-2024-00001
• Device Sequence Number: 7783415
• Product Code: NGT
• UDI-Device Identifier: 10859809005023
• UDI-Public: 10859809005023
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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: 2T0806
• Device Lot Number: KH05218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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