MAUDE Adverse Event Report: NAVILYST MEDICAL NAVILYST MEDICAL; STOPCOCK

Catalog Number H965700350091

Device Problem Air Leak (1008)

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

Event Date 06/11/2015

Event Type  malfunction  

Event Description

Hospital reports having an "ongoing issue with the 3-way stopcocks aspirating air during use." there has been no air injection into a patient.All used devices have been discarded.

Manufacturer Narrative

Although a used device is not expected to be available for evaluation, the investigation into this event is ongoing.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).

Manufacturer Narrative

A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The (b)(6) 2015 angiodynamics complaint report was reviewed for the stopcock/manifold product family and the failure mode, "air bubbles noted." no adverse trend was identified.The reported event of air aspiration is unable to be confirmed without a sample to examine.A potential root cause is that the end user did not adequately secure the connections between the stopcock and the device to which it was being connected.The directions for use packaged with the kit contains the statements: "ensure that you are making secure connections when using this device to prevent the introduction of air into the system.All connections should be finger tightened.Over tightening can cause cracks and leaks to occur.Examine product carefully for entrapped air and fully debubble prior to injection to minimize the potential for embolism." angiodynamics manufacturing process controls for the stopcock includes visual inspection for molding defects, verification that male tapers, female tapers, and female threads are within dimensional specification, and air leak/air flow testing.(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: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 4910217
• MDR Text Key: 6834485
• Report Number: 1317056-2015-00135
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K782095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2015

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: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: H965700350091
• Device Lot Number: 4818693
• Other Device ID Number: STOPCOCK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 07/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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