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

Model Number 2T0806

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

The clinician interviewed about this event, ms.(b)(6), rn, reported that two (2) events occurred involving pre-filled flush syringes where the luer tips broke off while the clinician was disconnecting the syringe from the fistula needle hub after performing the flush.The process of recannulating took approximately 20 minutes without any further complications suffered by the patient.

Event Description

Initial information about this event was provided to aquabiliti by (b)(4), a distributor.The information stated that their customer encountered several events where the luer tip of a flush syringe allegedly broke when disconnecting from a fistula needle, staying lodged in the hub.

• Brand Name: AQUASTAT 10ML/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: 6792327
• MDR Text Key: 82728521
• Report Number: 1057300-2017-00005
• 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: company representative
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/24/2019
• Device Model Number: 2T0806
• Device Catalogue Number: 2T0806
• Device Lot Number: KH04427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2017
• 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