N95 PARTICULATE RESPIRATOR
Received Aug 20, 2020 · Event occurred Aug 16, 2020
Report 10430407 · MDR key 10430407
Device
Product problems
- Break
- Product Quality Problem
Patient
29930 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
WHILE PROVIDING PATIENT CARE IN THE EMERGENCY ROOM, THE PIECE OF ELASTIC OF THE 3M N95 MASK BROKE CAUSING THE MASK TO FALL OFF. NOTABLY, ON THE SAME DAY, TWO OTHER NURSES REPORTED THE SAME PROBLEM, FORTUNATELY THEY WERE NOT PROVIDING PATIENT CARE AT THAT TIME. THREE DAYS LATER, TWO RNS REPORTED THE SAME PROBLEM; ONE WHILE PROVIDING PATIENT CARE. THE NURSES DESCRIBE THE ELASTIC EAR PIECES AS "STRETCHING OUT" AND "BREAKING." NURSES ON THE PATIENT UNITS HAVE MADE SIMILAR COMPLAINTS AND HAVE COMPLAINED THE 3M N95 FACE PORTION LOSES ITS SEAL. IN AN EFFORT TO CONSERVE LIMITED INVENTORY, HOSPITAL POLICY REQUIRES ONE MASK TO BE WORN FOR A TOTAL OF THREE 12-HOUR SHIFTS. MASKS ARE TO BE DISCARDED IF THEY BECOME SOILED OR DEFECTIVE IN ANY MANNER. IF THE PRACTICE OF WEARING THE SAME MASK FOR 3 SHIFTS IS NOT RECOMMENDED BY THE MANUFACTURER IT MUST BE CLEARLY STATED ON THE BOX.