MAUDE Adverse Event Report: AQUABILITI AQUASTAT; FLUSH SYRINGE

Model Number	2T0806
Medical Device Problem Code	Unexpected Color (4055)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Aquabiliti has been made aware of a discolored syringe.A picture is attached.Aquabiliti has not received the syringe back, despite making 3 requests.The person in charge is working remotely and says she is the only person that can assist, but unable to confirm when she will be back in the office.Nonetheless, the issue is believed to be due to some metal piece being embedded in the plunger tip material (the stopper) in the syringe which aquabilitio purchases.This alleged problem has been previously reported (las toccurrence in 2017), and our investigation determined that iron oxidation caused the observed discoloration of the saline in those cases, which appears similar to that seen in this complaint.
Event or Problem Description
Customer noticed discolored saline prior to use of aquastat 2t0806.

• Brand Name: AQUASTAT
• Common Device Name: FLUSH SYRINGE
• Manufacturer (Section D): AQUABILITI; 5209 linbar dr; ste 640; nashville TN 37211
• Manufacturer (Section G): AQUABILITI; 5209 linbar dr; ste 640; nashville TN 37211
• Manufacturer Contact: dipen patel ; 5209 linbar dr; ste 640; nashville, TN 37211
• MDR Report Key: 14806837
• Report Number: 1057300-2022-00001
• Device Sequence Number: 5074203
• Product Code: NGT
• UDI-Device Identifier: 20859809005020
• UDI-Public: (01)20859809005020(10)KH04905(17)231220(30)400
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/24/2022

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: 12/20/2023
• Device Model Number: 2T0806
• Device Lot Number: KH04905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown