MAUDE Adverse Event Report: AQUABILITI AQUASTAT; FLUSH SYRINGE

Model Number 2S0706

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Injection Site Reaction (4562)

Event Date 02/08/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 311206522
• Report Number: 1000151124-2023-00001
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 20859809005006
• UDI-Public: (01)20859809005006(10)KH05007(17)241005(30)240
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2S0706
• Device Lot Number: KH05007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Date Device Manufactured: 10/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention