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

Model Number 2T0806

Device Problems Nonstandard Device (1420); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/05/2016

Event Type  malfunction  

Event Description

One of our distributors reported that one of their clients stated they had two (2) syringes with brown colored saline.

• 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 (Section G): AQUABILITI; 5209 linbar drive; ste 640; nashville TN 37211
• Manufacturer Contact: dave meily ; 5209 linbar drive; ste 640; nashville, TN 37211 ; 6158332633
• MDR Report Key: 5909737
• MDR Text Key: 53294815
• Report Number: 1000151124-2016-00005
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2017
• Device Model Number: 2T0806
• Device Catalogue Number: 2T0806
• Device Lot Number: KH04244
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other