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

Model Number 2T0805

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

A return material authorization was issued to st.Jude medical for the return of all product in lot kh04195.No failures detected as a result of 100% visual inspection and no microbial contamination observed in both the affected sample and a retained sample.

Event Description

One of our distributors received a phone call from their hospital client stating that 0.9% sodium chloride solution syringe (model 2t0805) was contaminated and they will have to return (the product).

• Brand Name: AMUSA FLUSH SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): AQUABILITI; 5209 linbar drive; ste 640; nashville TN 37211
• Manufacturer Contact: john beasley ; 5209 linbar dr; ste 640; nashville, TN 37211 ; 6158332633
• MDR Report Key: 5867376
• MDR Text Key: 51940356
• Report Number: 1000151124-2016-00003
• 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: 08/08/2016

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
• Device Operator: No Information
• Device Expiration Date: 05/31/2017
• Device Model Number: 2T0805
• Device Catalogue Number: 2T0805
• Device Lot Number: KH04195
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 08/10/2016
• Date Device Manufactured: 05/05/2015
• 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