MAUDE Adverse Event Report: NAVILYST MEDICAL NAVILYST MEDICAL; CONVENIENCE KIT

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2014

Event Type  malfunction  

Event Description

As reported by a sales representative for navilyst medical's distributor in (b)(4), a hospital is utilizing a convenience kit which includes a fluid delivery set with a drip chamber.During preparation, when they pull back on the plunger of the syringe to aspirate saline, air bubbles are generated, which then remain within the device tubing.No patient complications or injuries have resulted from this event.

Manufacturer Narrative

Navilyst medical has provided our (b)(4) distributor's sales rep with multiple questions regarding the event including requests for item numbers, lot numbers, samples, and additional event description.As such, the investigation is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.

• Brand Name: NAVILYST MEDICAL
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): NAVILYST MEDICAL; glens falls NY 12801
• Manufacturer (Section G): NAVILYST MEDICAL; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: michael duerr ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424571
• MDR Report Key: 4232594
• MDR Text Key: 5070430
• Report Number: 1317056-2014-00055
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: FLUID DELIVERY SET
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2014
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1