MAUDE Adverse Event Report: AQUABILITI AMUSA FLUSH SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Model Number 2T0806

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

Patient Problem No Patient Involvement (2645)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

Component manufacturer (for the tip of the syringe plunger) reported occasional shards of metal from their process can become lodged in the material that is used for the injection molding process.They indicated several quality control inspections exist in their production line to catch any plunger tips that have any metal in them, but admit that this is a possible occurrence.

Event Description

Opened a new box of ns flush (syringes) and the solution appeared to have a rusty color.Color was noted prior to opening the individual package.

• Brand Name: AMUSA FLUSH SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): AQUABILITI; 5209 linbar dr; suite 640; nashville TN 37211
• Manufacturer Contact: john beasley ; 5209 linbar dr; ste 640; nashville, TN 37211 ; 6158332633
• MDR Report Key: 5854465
• MDR Text Key: 51841092
• Report Number: 1000151124-2016-00002
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2017
• Device Model Number: 2T0806
• Device Catalogue Number: 2T0806
• Device Lot Number: KH04208
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/28/2015
• Date Device Manufactured: 07/14/2015
• 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
• Patient Outcome(s): Other