AIRLIFE¿ NASAL OXYGEN CANNULA CURVED, FLARED TIP WITH 7 FOOT (2.1 M) CRUSH-RESIS
Received Dec 14, 2023 · Event occurred Nov 6, 2023
Report 8030673-2023-00361 · MDR key 18331315
Device
Generic name
Cannula, Nasal, Oxygen
Manufacturer
Vyaire MedicalModel number
001365Catalog number
001365
Lot number
NOT PROVIDED
Product problems
- Disconnection
- Disconnection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE END THAT CONNECTS TO THE WALL OXYGEN IS MUCH MORE DIFFICULT TO CONNECT TO THE GREEN CHRISTMAS TREE. THE PATIENT EXPERIENCED DESATURATION TO 88%. WHEN THEY LOOKED AT THE 001365 - CANNULA NASAL FLARD W/U-CONNECT-IT, IT HAD DISCONNECTED FROM THE WALL. THEY RECONNECTED THE TUBE TO THE WALL, AND SATURATION INCREASED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE EVENT.
Additional Manufacturer Narrative
OTHER 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. DEVICE NOT RETURNED YET.
Additional Manufacturer Narrative
H11:CORRECTION. D4:CORRECTED MODEL #. SECTION D4 WAS UPDATED TO INDICATE CORRECT MODEL #.