MAUDE Adverse Event Report: NAVILYST MEDICAL NAVILYST MEDICAL; STOPCOCK

Catalog Number H965700350081

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2014

Event Type  malfunction  

Event Description

As reported by navilyst medical's distributor in (b)(6), an end user hospital reported that an air leak occurred with a navilyst medical stopcock during prep.No patient injury was reported.The stopcock was discarded at the hospital.

Manufacturer Narrative

A review of the device history records was performed for the reported packaging lot for any deviations related to the reported defect fo the complaint.The review confirms that the lot met all material, assembly and performance specifications.The navilyst medical june 2014 complaint report was reviewed for the product family of stopcocks/manifolds and the failure mode, "air bubbles".No adverse trends were identified.The reported event is unable to be confirmed and a root cause unable to be determined as no device was returned for evaluation.Navilyst medical manufacturing process controls for this device include visual inspection for damage or defects, verification that tapers and threads are within specification, handle torque testing, and air leak/air flow testing.

• Brand Name: NAVILYST MEDICAL
• Type of Device: STOPCOCK
• 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: 4093066
• MDR Text Key: 4743463
• Report Number: 1317056-2014-00054
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K782095
• 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: 08/26/2014

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: 12/31/2016
• Device Catalogue Number: H965700350081
• Device Lot Number: 4696971
• Other Device ID Number: STOPCOCK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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