MalfunctionMSH
N95 1860
Received Jan 11, 2021 · Event occurred Dec 11, 2020
Report 11146551 · MDR key 11146551
Device
Product problems
- Loose or Intermittent Connection
- Defective Device
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IN (B)(6), NURSES BEGAN REPORTING CONCERNS ABOUT THE WAY THEIR N95'S FIT AND FELT. THEY DESCRIBED THE MASKS AS FEELING THINNER, STRAPS FELT LOOSE, AND WERE UNABLE TO OBTAIN A SEAL AND IN GENERAL "DID NOT FEEL RIGHT". THESE MASKS WERE DISTRIBUTED TO THE HOSPITAL BY 3M FROM AN OUTSIDE VENDOR. 3M WAS NOT THE MANUFACTURER OF THESE MASKS. SUPPLY CHAIN INFORMED 3M OF THIS ISSUE. ALL MASKS WITH THE LOT NUMBERS LISTED WERE IMMEDIATELY PULLED FROM THE HOSPITAL SHELVES AND RETURNED TO 3M.