MAUDE Adverse Event Report: AQUABILITI AQUASTAT 10ML/12ML SINGLE DOSE FLUSH SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Model Number	2S0706
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Problem reported to aquabiliti by convenience kit manufacturer (see their complaint (b)(4)).The convenience kit manufacturer did not report to fda.The aquastat product is sterilized by gamma, which is dependent on a verification dose based on monitored bioburden levels.Given the product is contaminated by a hair, the level of bioburden and its impact on the sterilization process are unknown.
Event or Problem Description
Customer reported an end user discovered one of aquabiliti's sterile field ready syringe contained a foreign object (hair) in the saline.The syringe was not utilized for the patient's treatment.

• Brand Name: AQUASTAT 10ML/12ML SINGLE DOSE FLUSH SYRINGE
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): AQUABILITI; 5209 linbar drive; ste 640; nashville TN 37211
• MDR Report Key: 6180012
• Report Number: 1000151124-2016-00008
• Device Sequence Number: 10997487
• Product Code: NGT
• UDI-Device Identifier: 00859809005002
• UDI-Public: 859809005002
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K120836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/16/2016

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: 04/30/2018
• Device Model Number: 2S0706
• Device Catalogue Number: 2S0706
• Device Lot Number: KH04312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2016
• Initial Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1