MalfunctionMSH
3M AURA HEALTH CARE PARTICULATE RESPIRATOR AND MASK
Received May 23, 2018 · Event occurred May 3, 2018
Report 7536640 · MDR key 7536640
Device
Product problems
- Fitting Problem
- Material Deformation
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
NURSE STATES THAT OCCASIONALLY SHE WILL OPEN A BRAND NEW N95 1870 MASK FOR EMPLOYEE FIT TESTING AND NOTICE THAT THE TOP FOLD OF THE MASK (WHICH WOULD GO OVER THE NOSE) IS BUNCHED UP, AS IT WILL NOT STRAIGHTEN COMPLETELY OUT, THUS PREVENTING A GOOD PROTECTIVE SEAL FIT. SHE NOTES THAT IT IS NOT ON ALL OF THEM JUST PERIODICALLY COMES ACROSS THEM. CONCERN THAT IF STAFF USE ONE OF THESE THAT IS BUNCHED UP DURING REAL PATIENT CARE THE SEAL WILL NOT BE COMPLETE AS THEY WERE FIT TESTED, THUS PUTTING THEM AT RISK FOR EXPOSURE. JUST A SAFETY CONCERN WE WOULD LIKE TO REPORT.