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

Model Number 2S0706

Device Problems Product Quality Problem (1506); Material Deformation (2976); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 02/04/2016

Event Type  malfunction  

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 31 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.(b)(4) samples were evaluated, and all packaging was sealed.The samples contained deformations on or near seals that was not desirable.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 (b)(4) 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 Description

Customer reported product packaging deformations on the syringe's pouch seals.

• Brand Name: AQUASTAT 10ML/12ML SINGLE DOSE FLUSH SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): AQUABILITI; 5209 linbar drive; suite 640; nashville TN 37211
• Manufacturer Contact: dave meily ; 5209 linbar drive; suite 640; nashville, TN 37211 ; 6158332633
• MDR Report Key: 6737822
• MDR Text Key: 80901186
• Report Number: 1057300-2017-00004
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00859809005002
• UDI-Public: 859809005002
• 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: company representative
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device Expiration Date: 07/31/2017
• Device Model Number: 2S0706
• Device Catalogue Number: 2S0706
• Device Lot Number: KH04252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1