MAUDE Adverse Event Report: NAVILYST MEDICAL NAVILYST MEDICAL; STOPCOCK

Catalog Number H965700350031

Device Problems Hole In Material (1293); Device Packaging Compromised (2916)

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

Event Date 12/01/2014

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 box of 50.The entire box was returned to navilyst medical by the warehouse.

Manufacturer Narrative

A review of the dhr was performed for the reported packaging lot for any deviations related to the reported defect of the complaint.The review confirms that the lot met all material, assembly, and performance specifications.The navilyst medical (b)(6) 2014 complaint report was reviewed for product family of stopcocks/manifolds and the failure mode, "hole in pouch".No adverse trends were identified.The returned sample was visually inspected and the hole in the pouch was confirmed.As part of the receiving process at nipro (the distributor in (b)(6)), all pouched products are removed from their inner boxes and a nipro label (in (b)(6)) is applied to each pouch.Additional handling may occur if the pouches are 100% visually inspected.The pouched product is then re-boxed into the inner box by the nipro warehouse employees.The hole in the tyvek was likely caused by the handle of the stopcock, however, what caused the handle to be pushed against the tyvek in a manner that resulted in a hole cannot be determined.Potential contributing factors include: over-crowding of filled pouches in the in-process bins or improper handling of pouches as they are placed in inner boxes at navilyst medical.Handling during transit to the nipro warehouse.Handling at nipro during the labeling/inspection and re-boxing process.All pouches are 100% inspected per navilyst medical procedures during the sealing and the final box processes.The directions for use (dfu) for the stopcocks contain the following warning: "contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged.

• 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: 4417452
• MDR Text Key: 5376675
• Report Number: 1317056-2015-00001
• 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: 12/09/2014

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: 09/30/2014
• Device Catalogue Number: H965700350031
• Device Lot Number: 4807038
• Other Device ID Number: STOPCOCK
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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