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

Catalog Number H749600411611

Device Problems Bent (1059); Device Disinfection Or Sterilization Issue (2909)

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

Event Type  malfunction  

Event Description

As reported, the tyvek lid on the hard plastic tray containing the navilyst medical convenience kit was partially open due to the corner of the tray being bent.This compromised the sterility of the kit.The kit was used on a pt and was discarded by the hospital.

Manufacturer Narrative

A review of the device history records was performed 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 (b)(6) 2014, navilyst medical complaint report was reviewed for the convenience kit product family and the failure mode, "unsealed pouch/tray".No adverse trends were identified.Although the device was not returned for eval, the event description of the tray lid being open due to the corner of the tray being bent indicates that the kit incurred handling damage after leaving the navilyst medical facility.A damaged tray would not sit properly in the tray sealer and could not be sealed properly.All kits are 100% inspected at both the sealing and final boxing processes for complete and defect-free tray seals.The directions for use packaged with the convenience kits contain the warning: "contents supplied sterile.Do not use if sterile barrier is damaged.Inspect prior to use to verify that no damage has occurred during shipping".(b)(4).

• Brand Name: NAVILYST MEDICAL
• Type of Device: COVENIENCE 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: 4230030
• MDR Text Key: 16089060
• Report Number: 1317056-2014-00061
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: H749600411611
• Device Lot Number: 4770835
• Other Device ID Number: CONVENIENCE KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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