CATHETER SUCT DRY RIGID 08FR KIT

Additional Manufacturer Narrative

RESULT OF INVESTIGATION: THE VYAIRE INVESTIGATION TEAM WAS UNABLE TO DUPLICATE THE ISSUE REPORTED BY THE CUSTOMER. THE SAMPLE WAS EVALUATED ACCORDING TO (B)(4) PERFORMING A VISUAL INSPECTION AND A FUNCTIONAL TEST (SUCTION TEST) GETTING ACCEPTABLE RESULTS. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED AND NO ISSUES WERE FOUND.

Additional Manufacturer Narrative

VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED TO VYAIRE MEDICAL THAT A REGISTERED NURSE WAS CALLED TO A PATIENT'S BEDSIDE TO ASSIST WITH SUCTIONING THROUGH AN ENDOTRACHEAL TUBE. WHILE ATTEMPTING TO OPEN SUCTION, THE CATHETER WAS GETTING STUCK BEFORE THE LENGTH NEEDED TO PROPERLY SUCTION. THE REGISTERED NURSE NOTICED THAT THE TUBE APPEARED DEFECTIVE. THE CATHETER WAS IMMEDIATELY CHANGED OUT AND THE ISSUE WAS CORRECTED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.