MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS CO-AXIAL BREATHING CIRCUIT, ADULT, DISPOSABLE, 2.4 M/96 IN WITH GA; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number BREATHING CIRCUIT

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

Vyaire has reached out to customer to provide the complaint device for further investigation.At this time we are currently waiting for the sample.If the customer provides the sample for further investigation or additional information is obtained, vyaire will provided a follow up emdr.

Event Description

A customer contacted vyaire to report that two circuits had come apart at the end where the licorice stick connects.The customer confirmed that the internal & external tubing came unstuck.There was patient involvement; however, no patient injury or harm was indicated.

Manufacturer Narrative

H10 comment: the sample photo was received and analyzed.The reported issue was confirmed from the photo; however, a root cause could not be determined since the sample was not returned for evaluation.Furthermore, a device history record (dhr) of the lot number revealed no issues during the manufacturing process.Corrective/preventive actions were indicated.

• Brand Name: VITAL SIGNS CO-AXIAL BREATHING CIRCUIT, ADULT, DISPOSABLE, 2.4 M/96 IN WITH GA
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9176743
• MDR Text Key: 170462400
• Report Number: 3004050971-2019-00003
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BREATHING CIRCUIT
• Device Catalogue Number: M1152225
• Device Lot Number: 182633
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other