MAUDE Adverse Event Report: NAVILYST MEDICAL NAVILYST MEDICAL ; CONTRAST INJECTION LINE

Catalog Number H965910013031

Device Problem Hole In Material (1293)

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

Event Date 02/17/2015

Event Type  malfunction  

Event Description

As reported by navilyst medical's distributor in (b)(4), in the distributor's warehouse, a small hole was found in the mylar portion of the contrast injection line pouch, breaching the sterility.The device had not provided to a hospital and was returned to navilyst medial for evaluation.

Manufacturer Narrative

The sample from the reported event has been returned to navilyst medical, and the issue has been confirmed.As the investigation into the cause of the event in on-going, a supplemental medwatch will be submitted upon conclusion of the investigation.(b)(4).

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 angiodynamics (b)(6) 2015 complaint report was reviewed for the product family of contrast injection lines 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.The hole was in the mylar side of the pouch and is located near the rotating adaptor of the contrast injection line.The "flap" of the hole was pointing outward, but it is difficult to determine if something from the inside of the pouch pushed outward to create the hole, or if something from the outside dug into the pouch.The pouch size is appropriate for the device and the number of pouches per inner box is also appropriate.Although the returned sample did not have a nipro label applied to the pouch,as part of the receiving process at nipro all pouches are removed from their inner boxes and a nipro label (in (b)(6)) is applied to each pouch and inner box.Additional handling may occur if product is 100% visually inspected.The pouches are then re-boxed into the inner boxes by the nipro warehouse employees.The cause of the hole in the pouch is unable to 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 angiodynamics 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 (e) 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 and to improve the probability of identifying the defect in the future.

• Brand Name: NAVILYST MEDICAL
• Type of Device: CONTRAST INJECTION LINE
• 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: 4631269
• MDR Text Key: 5576873
• Report Number: 1317056-2015-00076
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K822100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 02/19/2015

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: 09/30/2017
• Device Catalogue Number: H965910013031
• Device Lot Number: 4807585
• Other Device ID Number: CONTRAST INJ LINE
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/25/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 03/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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