MAUDE Adverse Event Report: VYAIRE MEDICAL, INC ADAPTER NEO-VERSO INFANT/NEO Y W/DIR CON; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number CSC300

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

A sample has been provided.The sample was sent to the manufacturer of the device to complete the evaluation.Once the investigation is complete a follow up submission will be filed.

Event Description

Small silicone gasket came dislodged from the adapter tip and was stuck in the adapter tip so that the catheter csc208 could not pass down the endotracheal tube.There was no patient injury.

Manufacturer Narrative

One sample was returned and evaluated.The reported issue could not be confirmed as the sample received did not show any defect of a disconnection of the silicone structures.In addition, the sample was tested with a catheter and the catheter was able to be easily passed and there was no blockage noted.The dhr was reviewed and no issues were found.Since the complaint cannot be confirmed there are no corrective actions that can be implemented.We will continue to track and trend this issue.

• Brand Name: ADAPTER NEO-VERSO INFANT/NEO Y W/DIR CON
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 north riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): AOK TOOLING LIMITED; no.3 longtian 3 road,; longtian community,; pingshan district, shenzhen ; CH
• Manufacturer Contact: mindy faber ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6827409
• MDR Text Key: 83881343
• Report Number: 2050001-2017-00065
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CSC300
• Device Lot Number: 201612250001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CSC208
• Patient Outcome(s): Required Intervention