MAUDE Adverse Event Report: NAVILYST MEDICAL NAVILYST MEDICAL; STOPCOCK

Catalog Number H965700550081

Device Problems Hole In Material (1293); Device Disinfection Or Sterilization Issue (2909)

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

Event Date 04/03/2014

Event Type  malfunction  

Event Description

As reported by navilyst medical's distributor in (b)(6), a pouch containing a stopcock was noted, in their warehouse, to have a small hole in the tyvek side, thus the stopcock was no longer sterile.The sample was returned to navilyst medical.

Manufacturer Narrative

A review of the device history records (dhr) was performed for the reported packaging lot (4712955) 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)(4) 2014 complaint report was reviewed for the product family of stopcocks/manifolds and the failure mode of "hole in the pouch." no adverse trends were indicated.The reported event was confirmed, as the returned a sample contained a small hole in the tyvek portion of the stopcock pouch.The most likely root cause for this incident is handling after the package left the navilyst medical facility.The pouches are 100% inspected during the sealing process per navilyst medical procedures, and this is an obvious defect that would have been detected.No correction is required at this time since the root cause for this event has been deemed handling damage.Based on the low frequency, no recent trends, no issues noted in the dhr, and adequate process controls in place, no corrective action to be taken at this time.(b)(4).

• Brand Name: NAVILYST MEDICAL
• Type of Device: STOPCOCK
• 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: 3941038
• MDR Text Key: 18070517
• Report Number: 1317056-2014-00025
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K842829
• 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: 04/04/2014

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: Other
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: H965700550081
• Device Lot Number: 4712955
• Other Device ID Number: STOPCOCK
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/11/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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