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

Model Number	2S0706
Medical Device Problem Codes	Unsealed Device Packaging (1444); Device Packaging Compromised (2916); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This retrospective mdr is filed as a correction to an audit conducted december 2016 by a former fda investigator (consultant).We observed the package seal was compromised - the upper and lower tabs were pulled back more than normal.The cause is unknown, and might have happened due to handling at the customer or at our facility (b)(4).We subjected the returned syringe to a dye penetration test and the seal failed.This pouch was producted on a multivac form-fill-seal machine, and this particular sample was from cavity #20.Production inspection includes dye penetration, peel strength, and seal quality (visual).A review of the device history record showed acceptable performance results throughout the production for this lot for these three (3) inspections - i.E., all inspection samples met acceptance criteria.The customer returned their shipment of (b)(4) syringes.We subjected the syringes from the same intermediate carton as the alleged sample to dye penetration testing, which included syringes in pouches from cavity #20.All samples passed.We evaluated the remaining (b)(4) syringes.All products, other than the alleged product, met specifications.Zero defective seals were observed from this further evaluation.Sixty (b)(4) retain samples from lot kh04249 were evaluated, and all seals met specification.We reviewed the historical customer complaint data for the same product code (2s0706) for the year 2015 and did not find any similar package seal complaints.A further review of corrective actions taken since the manufacture of this lot of products (nov-2105) revealed that an increase in the top and bottom film used to form the package was made and validated in march-2016.No cause has been found for the reported problem and improvements have since been made in the packaging with no additional complaints of this type.
Event or Problem Description
During aql inspection, a syringe seal was found to be compromised.The customer (convienence kit manufacturer) rejected the lot based on this incident.

• 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: 6182764
• Report Number: 1000151124-2016-00010
• Device Sequence Number: 520799
• Product Code: NGT
• UDI-Device Identifier: 00859809005002
• UDI-Public: 859809005002
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2016

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: Other
• 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: 01/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2016
• 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