MAUDE Adverse Event Report: AQUABILITI AQUASTAT 5ML/12ML SINGLE DOSE FLUSH SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Model Number 2T0805

Device Problems Product Quality Problem (1506); Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

The sample was received from the complainant and a small piece of metal was observed partially imbedded in the rubber seal of the plunger causing discoloration of the saline.Further evaluation is being conducted on the contents of the syringe.

Event Description

Complainant encountered a 0.9% sodium chloride flush syringe that appeared to have "rust" in the solution.No patient involvement in this event.

• Brand Name: AQUASTAT 5ML/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: 6909081
• MDR Text Key: 88251355
• Report Number: 1057300-2017-00007
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00859809005019
• UDI-Public: 859809005019
• 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: company representative,user f
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device Expiration Date: 06/14/2019
• Device Model Number: 2T0805
• Device Catalogue Number: 2T0805
• Device Lot Number: KH04433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• 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