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 11/15/2017

Event Type  Injury  

Manufacturer Narrative

Initial emdr submission: sample is available, (b)(6) shipping labels provided to customer to have the sample returned.Currently waiting for the sample.Once the investigation is complete a follow up submission will be filed.

Event Description

The adapters were placed on the resmed vpap auto to the air outlet then to the patient cpap tubing.The u adapters melted at the nipple where the o2 tubing is attached, melted and elongated the plastic and sealed over so no o2 flow could pass through the adapter to the patient.No known injury to patients have been reported.

Manufacturer Narrative

No sample, no lot available however based on the customer stating the product was in use for 6 months.Our ifu states this product should not be used for longer than 30 days as the product can become deformed or discolored if used for longer that 30 days.The customer has been provided the ifu and instructed on the proper use of the device.

• 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
• 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 riverwoods blvd; mettawa, IL 60045
• MDR Report Key: 7061001
• MDR Text Key: 92998239
• Report Number: 8030673-2017-00386
• 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: health professional,user faci
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 004081-A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention