inforMED
MalfunctionMSH

KIMBERLY-CLARK N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK

Received Sep 3, 2020 · Event occurred Aug 4, 2020

Report 10487550 · MDR key 10487550

Device

Generic name

Respirator,surgical

Model number

46827

Catalog number

46827

Product problems

  • Break

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

AS REPORTED BY THE CATH LAB MANAGER, "WE HAVE CONSISTENTLY FOUND THAT WE ARE ATTEMPTING TO "DON" THESE MASKS, THE RUBBER STRAPS BREAK BEFORE WE'RE ABLE TO STRETCH THEM OVER OUR HEADS. HAVE HAD STAFF MEMBERS GO THRU MULTIPLES OUT OF A SINGLE BOX BEFORE THEY'LL FIND ONE THAT WILL GO ON WITHOUT BREAKING." THIS CONCERN HAS BEEN RAISED BY OTHER DEPARTMENTS WITHIN OUR HOSPITAL AS WELL.