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 12/04/2016

Event Type  malfunction  

Event Description

(b)(4) after completing the flush, the clinician proceeded to remove the syringe from the fistula needle and the luer from one of aquabiliti's syringes broke off and remained in the hub.The patient's fistula needle required replacing.Agreed to send the rejected syringe back to aquabiliti for evaluation if her corporate office advised her to comply.Attempts to reach her by phone on 08-dec-2016 @ 14:23 and 09-dec-2016 @12:53 were not successful in getting confirmation on the return of the defective syringe.

• 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: 6180009
• MDR Text Key: 62545101
• Report Number: 1000151124-2016-00007
• 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: K111034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/15/2016

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: 07/11/2018
• Device Model Number: 2T0806
• Device Catalogue Number: 2T0806
• Device Lot Number: KH04327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2016
• 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
• Patient Outcome(s): Required Intervention