MAUDE Adverse Event Report: VYAIRE MEDICAL, INC CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 004081-A

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

Vyaire will reach out to customer for sample availability and additional information.If the sample is obtained and further evaluation can be performed an update emdr will be provided.

Event Description

The customer reported: we are experiencing melting of the cardinal health o2 bleed-in adapter with use of a vent.We cannot replicate this in our test environment.The melting is happening at the nipple and what is most notable is the tapering of the port that restricts the flow of oxygen.

Manufacturer Narrative

Additional information : the sample was not available for further evaluation; however pictures were provided, and the melted/ deformed condition was confirmed.The customer stated that the product was in use for 3+ months.Per the products information or use (ifu) it states this product should not be used longer than 30 days as the product can become deformed or discolored.The customer has been provided the ifu and instructed on the proper use of the device.The complaint issues has been closed out to a root cause of customer misuse.

• Brand Name: CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 n riverwoods blvd; mettawa IL 60045
• MDR Report Key: 7262959
• MDR Text Key: 99797837
• Report Number: 8030673-2018-00412
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 004081-A
• Device Lot Number: 0001129863
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention