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

(b)(4): 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 bi level humidifier.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".

• 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 riverqwood; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL, INC; cerrada via de la produccion; no. 85 parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 26125 n riverwood blvd; mettawa, IL 60045
• MDR Report Key: 7262957
• MDR Text Key: 99777155
• Report Number: 8030673-2018-00411
• Device Sequence Number: 1
• Product Code: BZA
• 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: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2018

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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention