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

Model Number 2T0806

Device Problems Material Fragmentation (1261); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2015

Event Type  malfunction  

Event Description

Leur broke when removing the syringe from the catheter hub.The clinician interviewed about the event, (b)(6), rn reported that the same failure had occurred approximately 3 weeks prior to this event.There was no harm or injury to the patient in either incidents.During this event, the removal process of the lodged leur in the hub took approximately 40 minutes without any further complications suffered by the patient.

• Brand Name: AQUASTAT 10ML/12ML SINGLE DOSE FLUSH SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): AQUABILITI; 5209 linbar dr; ste 640; nashville TN 37211
• Manufacturer Contact: dave meily ; 5209 linbar dr; ste 640; nashville, TN 37211 ; 6158332633
• MDR Report Key: 6182735
• MDR Text Key: 62711959
• Report Number: 1000151124-2016-00011
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00859809005026
• UDI-Public: 859809005026
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: 2T0806
• Device Catalogue Number: 2T0806
• Device Lot Number: KH04158
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2014
• 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): Required Intervention