MAUDE Adverse Event Report: AQUABILITI AQUASTAT; FLUSH SYRINGE

Model Number	2S0706
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Injection Site Reaction (4562)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Aquabiliti reviewed the device history record (dhr) and there were no non-conformances noted during the production of lot # kh05007.A review of the sterilization records also displayed no irregularities.No other adverse reactions have been reported from this production lot (qty: (b)(4)) by this or any other facility.
Event or Problem Description
An aquabiliti flush syringe (2s0706) was used via the patient's access port.The patient immediately indicated they were not feeling well.The tending clinicians then noted that it appeared as though the patient was having an allergic reaction, as his/her skin appeared red in color.From the information provided: per nursing report: last wednesday february 8, above patient was scheduled for chemotherapy treatment.Right after the nurse accessed the port following the hospital protocol using the sterile normal saline flush, the patient stated was not feeling well and vital signs became unstable.App came to assess the patient and noticed an allergic reaction on her arms-hives/redness - and swollen lips.After patient was stabilized, she was transferred via 911 to the er.

• 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 ; 6158332633
• MDR Report Key: 16533987
• Report Number: 1000151124-2023-00001
• Device Sequence Number: 20430207
• Product Code: NGT
• UDI-Device Identifier: 20859809005006
• UDI-Public: (01)20859809005006(10)KH05007(17)241005(30)240
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120836
• 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): 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2024
• Device Model Number: 2S0706
• Device Lot Number: KH05007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/13/2023
• Date Device Manufactured: 10/06/2022
• 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: Required Intervention
• Patient Sex: Unknown