MAUDE Adverse Event Report: AQUASTAT 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

Information provided by the user facility, stated that a previous incident involving a broken luer had occurred approximately 3 weeks prior reported as 1057300-2017-00005.There was no harm or injury to the patient in either incidents.

Event Description

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): AQUASTAT; 5209 linbar drive; suite 640; nashville TN 37211
• Manufacturer Contact: dave meily ; 5209 linbar drive; suite 640; nashville, TN 37211 ; 6158332633
• MDR Report Key: 6792776
• MDR Text Key: 82820106
• Report Number: 1057300-2017-00006
• 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
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1