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

Model Number 2S0706

Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

This retrospective mdr is filed in response to a quality audit conducted (b)(6) 2017 by a former fda investigator (consultant).

Event Description

(b)(4) access systems' incoming inspection found one of the aquabiliti sterile field ready products with an open pouch.(b)(4) access systems uses the aquabiliti's 2s0706 product as a component in the kits they market / distribute.

• Brand Name: AQUASTAT 10ML/12ML SINGLE DOSE FLUSH SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): AQUABILITI; 5209 linbar drive; ste 640; nashville TN 37211
• Manufacturer Contact: dave meily ; 5209 linbar ave; ste 640; nashville, TN 37211 ; 6158332633
• MDR Report Key: 6180018
• MDR Text Key: 62541984
• Report Number: 1000151124-2016-00009
• 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: other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2017
• Device Model Number: 2S0706
• Device Catalogue Number: 2S0706
• Device Lot Number: KH04264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1