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

Model Number 2S0706

Device Problems Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

Problem reported to aquabiliti by convenience kit manufacturer (see their complaint (b)(4)).The convenience kit manufacturer did not report to fda.The aquastat product is sterilized by gamma, which is dependent on a verification dose based on monitored bioburden levels.Given the product is contaminated by a hair, the level of bioburden and its impact on the sterilization process are unknown.

Event Description

Customer reported an end user discovered one of aquabiliti's sterile field ready syringe contained a foreign object (hair) in the saline.The syringe was not utilized for the patient's treatment.

• 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 drive; ste 640; nashville, TN 37211 ; 6158332633
• MDR Report Key: 6180012
• MDR Text Key: 62544422
• Report Number: 1000151124-2016-00008
• 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: 12/16/2016

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: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 2S0706
• Device Catalogue Number: 2S0706
• Device Lot Number: KH04312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• 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