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

Model Number	2S0706
Medical Device Problem Codes	Product Quality Problem (1506); Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/04/2016
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 fda investigator (consultant).We observed the packaging deformations.This product's sterile barrier packages are produced on a multivac form-fill-seal machine.The root cause was found to be unoptimized process parameters with the multivac.We subjected (b)(4) syringes returned by the customer to performance testing.The tests included peel strength, dye penetration, and seal quality (visual).All product inspected passed performance tests.Sixty (b)(4) retain samples were evaluated, and all sealed packaging met specifications.Production final inspection includes a visual check of all product.A review of the device history record showed that samples met in process performance testing and final inspection acceptance criteria.A review of corrective actions taken since the manufacture of these lots of product (nov.2015) revealed that minor equipment adjustments to the multivac were implemented and completed validation in march 2016.We reviewed historical complaint files since the improvements to the packaging and it shows no further complaints of this nature ytd (jul-2017).
Event or Problem Description
Customer reported product's sterile field ready flush syringe pouch contained deformations on the sealed portion of the pouch.

• Brand Name: AQUASTAT 10ML/12ML SINGLE DOSE SYRINGE
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): AQUABILITI; 5209 linbar drive; suite 640; nashville TN 37211
• MDR Report Key: 6730827
• Report Number: 1057300-2017-00003
• Device Sequence Number: 10976766
• 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
• Initial Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date (Section B): 07/20/2017

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: Service Personnel
• Device Expiration Date: 07/31/2017
• Device Model Number: 2S0706
• Device Catalogue Number: 2S0706
• Device Lot Number: KH04249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2016
• Initial Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1