MAUDE Adverse Event Report: NAVILYST MEDICAL, INC. NAMIC; CARDIOVASCULAR PROCEDURE KIT

Model Number 65210091

Device Problem Air Leak (1008)

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

Event Date 01/16/2018

Event Type  malfunction  

Event Description

The manifolds that are in the new packs from cardinal have one-way valve on the waste port.Because of this valve, air can be introduced into the manifold, which is supposed to be an air-less system.Also, the syringes that come in the pack are not able to be refilled quickly enough without introducing air into the syringe.Manufacturer response for namic convenience kit, (brand not provided) (per site reporter): the rep has been contacted in hopes to refund the cost of the kits that were purchased.

• Brand Name: NAMIC
• Type of Device: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): NAVILYST MEDICAL, INC.; 26 forest st; marlborough MA 01752
• MDR Report Key: 7273513
• MDR Text Key: 100196891
• Report Number: 7273513
• Device Sequence Number: 1
• Product Code: OEZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2020
• Device Model Number: 65210091
• Device Catalogue Number: 65210091
• Device Lot Number: 5262713
• Other Device ID Number: UPN/PRODUCT #: H965652100910
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1