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

Model Number	2S0706
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This retrospective mdr is filed as a correction to an audit conducted 06-jun-2017 by a former (b)(4) investigator (consultant).We observed the syringe was dirty with a surface grease-like substance that was confined to the end of the barrel of the syringe, but no loose particulate matter.Production final inspection includes a visual check of all product.A review of the device history record showed that samples met in process and final inspection acceptance criteria.Sixty (60) retain samples from lot kh04306 were evaluated, and zero defected syringes were observed.We reviewed the historical customer complaint data and cars for the same product code (2s0706) for the year 2015 and did not find any similar dirty syringe complaints.Customer reported 106 syringes, but further investigation by the customer revealed that the true number of rejected syringes was actually three (3).The original reported number was determined to be inadequate training of the customer's personal on specifications.It was determined that the syringe was received from the supplier as dirty.The supplier was notified and no conclusive root cause had been received at the processing time of this complaint.
Event or Problem Description
During aql inspection, customer reported 106 syringes were found with particulate matter contained within syringe pouches.

• Brand Name: AQUASTAT 10ML/12ML SINGLE DOSE FLUSH SYRINGE
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): AQUABILITI; 5209 linbar drive; suite 640; nashville TN 37211
• MDR Report Key: 6725899
• Report Number: 1057300-2017-00001
• Device Sequence Number: 10983348
• 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: company representative,other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/18/2017

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: Other
• Device Expiration Date: 04/11/2018
• Device Model Number: 2S0706
• Device Catalogue Number: 2S0706
• Device Lot Number: KH04298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2016
• Initial Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1