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

Catalog Number H965606919071

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

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

Event Date 10/15/2014

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 convenience kit pouch, breaching the sterility.The kit was one in a box of 10.The kit had not been provided to a hospital and was returned to navilyst medical for evaluation.

Manufacturer Narrative

A review of the device history records 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 september 2014 complaint report was reviewed for the product family of convenience kits and the failure mode, "hole in pouch." no adverse trends were identified.The returned sample was visually inspected and the hole in th pouch was confirmed.Additionally, the pouch was noted to have had a nipro ((b)(6) distributor) label applied to the tyvek side of the pouch.As part of the receiving process at nipro, all pouched products are removed from their inner boxes an a nipro label (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 cause of the hole in the tyvek of the pouch may have been a result of the handle of the device in the pouch; devices with handles are placed in the pouch with handle against the tyvek.However, review of the hole may indicate that the hole came from the outside of the pouch toward the inside based on the wrinkle of the tyvek near the hole.The ultimate root cause of the hole cannot be determined.Potential factors contributing to the damage include: handling of the pouches as they are placed in the inner boxes, handling during transit to 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 final box processes.The directions for use (dfu) included with the kits contain the following warning: "contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged." all packaging employees have been made aware of this complaint in order to improve their awareness of the defect an to improve the probability of identifying the defect in the future, (b)(4).

• Brand Name: NAVILYST MEDICAL
• Type of Device: CONVENIENCE 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: 4254205
• MDR Text Key: 20067065
• Report Number: 1317056-2014-00074
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/15/2014

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: 08/31/2017
• Device Catalogue Number: H965606919071
• Device Lot Number: 4785052
• Other Device ID Number: CONVENIENCE KIT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/23/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2014
• Initial Date FDA Received: 11/10/2014
• 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