MAUDE Adverse Event Report: NAVILYST MEDICAL NAVILYST MEDICAL; STOPCOCK

Catalog Number H965700350081

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2014

Event Type  malfunction  

Event Description

As reported by navilyst medical's distributor in (b)(6), in the distributor's warehouse, a small hole was found in the tyvek portion of the stopcock pouch, breaching the sterility.The stopcock was one in a (b)(4).The entire box was returned to navilyst medical by the warehouse.

Manufacturer Narrative

The device that was the subject of the complaint has been returned to navilyst medical for evaluation.Upon completion of the investigation into this incident, a supplemental medwatch will be submitted.

• 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: 3928354
• MDR Text Key: 4601610
• Report Number: 1317056-2014-00038
• Device Sequence Number: 1
• Product Code: DTZ
• 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: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: H965700350081
• Device Lot Number: 4728748
• Other Device ID Number: STOPCOCK
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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