BOX,DISPOSABLE MOUTH PIECE
Received Jun 21, 2019 · Event occurred Mar 12, 2019
Report 2021710-2019-10388 · MDR key 8724547
Device
Generic name
Mouthpiece, Breathing
Manufacturer
Vyaire MedicalModel number
M/PIECES LG DISP BX150Catalog number
42157
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
Not reported
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
(B)(4). AT THIS TIME, VYAIRE HAS RECEIVED THE SUSPECTED MOUTHPIECE. DETAILS TO DETERMINE THE TYPE OF INVESTIGATION ARE NOT YET AVAILABLE, BUT ARE BEING SOUGHT. ANY ADDITIONAL INFORMATION WILL BE INCLUDED IN A FOLLOW-UP REPORT.
Description of Event or Problem
WHILE USING THE VMAX FOR PULMONARY FUNCTION TESTING, THE PATIENT'S LIPS WERE STICKING TO THE MOUTHPIECE AND CAUSING THEIR LIPS TO BLEED.
Additional Manufacturer Narrative
THE ISSUE WAS INTERNALLY INVESTIGATED. VYAIRE FAILURE ANALYSIS LAB RECEIVED THE PART AND PARTS WERE SENT TO THE SUPPLIER. THE SUPPLIER AND MANUFACTURER PROVIDED ROOT CAUSE AND CORRECTION: ROOT CAUSE: MANUFACTURER CONFIRMED THAT THEY HAD INITIALLY STOCKED TWO SIMILAR MATERIALS AND THAT THE WRONG MATERIAL WAS PICKED FOR THIS BATCH. CORRECTION: MANUFACTURER CONFIRMED THAT THEY NO LONGER STOCK THE OTHER MATERIAL SO THERE WILL BE NO CHANCE FOR CONFUSION IN THE FUTURE. THE OEM HAS ADDED A VISUAL INSPECTION REQUIREMENT DURING RECEIVING INSPECTION TO VERIFY THAT THE MATERIAL IS GLOSSY.