AIRLIFE¿ PEDIATRIC CUSHION NASAL CANNULA WITH 7 FOOT (2.1 M) CRUSH-RESISTANT OXY
Received Sep 19, 2022 · Event occurred Aug 23, 2022
Report 8030673-2022-00269 · MDR key 15452336
Device
Generic name
Nasal Oxygen Cannula, Basic
Manufacturer
Vyaire MedicalModel number
CANNULA SOFT PED W/U-CON 7FT TB 50/CSCatalog number
SFT2692
Lot number
0004208650
Product problems
- Inadequacy of Device Shape and/or Size
- No Flow
- Inadequacy of Device Shape and/or Size
- No Flow
Patient
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 CANNULA SOFT PED W/U-CON 7FT TB 50/CS DOES NOT REACH UP THE CUSTOMER'S NOSE, AND THE OPENING IS NARROW AND TOO SHORT. THE CUSTOMER WAS NOT ABLE TO GET ANY OXYGEN THROUGH THE CANNULA. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.
Additional Manufacturer Narrative
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.