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

Catalog Number H965606209611

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

As reported by navilyst medical's distributor in (b)(6), when priming the tubing in their angiographic convenience kit, the end user hospital was unable to eliminate air bubbles from the saline tubing.The kit was not used, and there was no patient injury.It was indicated that the kit would be returned to navilyst medical for evaluation.

Manufacturer Narrative

It has been indicated that the used product will be returned for evaluation, however it has not yet arrived.Upon receipt of the sample and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

• Brand Name: NAVILYST MEDICAL
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): NAVILYST MEDICAL; glens falls NY
• 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: 4379089
• MDR Text Key: 5239496
• Report Number: 1317056-2014-00124
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: H965606209611
• Device Lot Number: 4636556
• Other Device ID Number: CONVENIENCE KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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